Now loading.
Please wait.

Menu

877-755-3329

Info@Amendia.com

Careers at AMENDIA

Headquartered in a state of the art manufacturing facility in Marietta, Georgia, Amendia is a leading provider of innovative medical devices used during spinal surgical procedures. Founded in 2008, Amendia’s Mission is to exceed surgeon and patient expectations by creating effective solutions with disruptive technologies for medical devices combined with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders.


Please see below for the current openings at Amendia.

Job Description

CNC Operator/Technician

Overview:

Amendia is searching for a CNC Operator/Technician for our second shift (3-11:30pm), based in its Marietta, GA location. This position are for the operation of our Nexturn swiss style machines. These positions will involve offsets, set ups and eventually programming. This will require some technical training. We are willing to train the right individual. Training will be done on first shift and then transfer to second shift. This position reports directly to the Vice President of Manufacturing.

Essential Duties, Competencies & Responsibilities

  • Minimum 3 years CNC experience and/or 2 years’ technical degree
  • Standard G code understanding
  • Ability to interpret B/P's
  • Read basic measuring tools (mic, calipers, etc.)
  • Perform offsets, set ups and some programming
  • Knowledge of and experience with Fanuc and/or Mazak controls software
  • Second Shift (3-11:30pm)

Minimum Qualifications, Experience and Position Requirements

  • Detail oriented
  • Must be fluent in English
  • Show initiative, resourcefulness, creative thinking and adaptability
  • Ability to prioritize multiple projects
  • Ability to work well under stressful conditions with critical deadlines
  • Ability to communicate throughout all levels of the organization
  • Must be able to work in a fast-paced entrepreneurial environment with changing priorities

Preferred Qualifications & Experience

  • Associates Degree preferred

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Must be able to lift up to 30 lbs


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Benefits

  • Competitive salary and benefits
Job Description

Compliance Manager

Overview:

Amendia is searching for a Compliance Manager, based in its Marietta, GA location. This position will take the lead on developing, implementing, and maintaining Amendia’s compliance policies and procedures related to healthcare fraud, waste, and abuse. The Compliance Manager will be granted a high degree of autonomy to identify potential issues and develop solutions related to Stark Law, the Anti-Kickback Statute, the False Claims Act, HIPAA, PPSA, and the company’s day-to-day operations that relate to healthcare laws and regulations. The Compliance Manager will work closely with a variety of departments, including Finance & Accounting, Human Resources, Research & Development, Marketing, Quality & Regulatory, and Account Services. The Compliance Manager reports directly to General Counsel.

Essential Duties, Competencies & Responsibilities

  • Consults with the Corporate attorney as needed to resolve difficult legal compliance issues.
  • Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
  • Acts as an independent review and evaluation body to ensure that compliance issues/concerns within the organization are being appropriately evaluated, investigated and resolved.
  • Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
  • Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
  • Develops, initiates, maintains, and revises policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program.
  • Develops and periodically reviews and updates Standards of Conduct to ensure continuing currency and relevance in providing guidance to management and employees.
  • Collaborates with other departments (e.g., Risk Management, Internal Audit, Employee Services, etc.) to direct compliance issues to appropriate existing channels for investigation
  • Possess a strong familiarity with healthcare laws and regulations, including Stark Law, the Anti-Kickback Statute, the False Claims Act, HIPAA, PPSA, and others
  • Stay up-to-date on relevant updates and changes to, rulings on, and interpretations of healthcare compliance laws and regulations
  • Provide risk assessments and guidance to the company and its employees as to current or proposed business practices involving issues related to compliance
  • Review, develop, and maintain policies and procedures related to compliance with healthcare laws and regulations
  • Manage compliance reporting hotline, and investigate all allegations of non-compliance
  • Develop platforms to measure, track, and report on compliance initiatives and status
  • Create and present training and instruction regarding healthcare compliance
  • Work with Finance & Accounting Department to manage PPSA reporting
  • Manage vendor, hold accountable for delivery performance, on hand inventory, including freight spend and overall costs.

Minimum Qualifications, Experience and Position Requirements

  • Bachelor’s degree
  • 3+ years in a similar role at a healthcare-oriented employer
  • Strong sense of ethics and dedication to patient safety
  • Proficient in the use of Microsoft Outlook, Excel, Word, and PowerPoint
  • Ability to create professional reports and analyses
  • Self-motivated, creative, and solution-oriented
  • Extremely organized
  • High degree of accuracy and attention to detail
  • Exemplary teamwork, cooperation, and communication skills
  • Superb verbal and written communication abilities

Preferred Qualifications & Experience

  • Master’s or professional degree in a relevant field
  • Relevant certifications, including CHC, CHPC, CPC, RHIA, PMP, PgMP, or paralegal
  • Coding and reimbursement experience

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Travel & Benefits

  • Competitive salary and benefits
Job Description

Industrial Engineer - Intern

Overview:

Amendia is searching for a Industrial Engineer Intern, based in its Marietta, GA location. This position will work on projects and initiatives under the supervision of the Manufacturing Engineering staff. As part of the team, the intern will develop an understanding for the Manufacturing processes and develop methods, tools, and documentation to support lean manufacturing and improve the overall product flow. This role reports to the Senior Engineering Manager.

Essential Duties, Competencies & Responsibilities

  • Utilize AutoCAD to develop facility layout drawings of production and support areas
  • Conduct studies and propose improvements to the overall process flow and spatial utilization based on Lean Manufacturing principles
  • Perform time studies and update time standards
  • Create and update documentation for manufacturing standard of work
  • Evaluate data collection systems, make recommendations and updates
  • Evaluate ergonomics and safety within the Manufacturing operations

Minimum Qualifications, Experience and Position Requirements

  • Junior level standing or higher in engineering course work leading to an Industrial Engineering degree from an accredited 4-year college or university.
  • Ability to perform assigned tasks and complete work on schedule with minimal supervision.
  • Eagerness to learn and accept challenges
  • Able to handle multiple tasks
  • Good communication skills
  • Working knowledge of computer programs (Microsoft Word, Excel, Outlook)
  • Experience with AutoCAD

Preferred Qualifications & Experience

  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
  • Being detail-oriented while having the ability to handle multiple projects/tasks
  • Demonstrate high quality standards
  • High attention to detail

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Ability to travel independently to clients; some air travel may be required.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Travel & Benefits

Competitive salary and benefit package.

Job Description

Maintenance Techniciann

Overview:

Amendia is searching for a Maintenance Technician, based in its Marietta, GA location. This role reports to the Vice President of Manufacturing.
Only qualified candidates will be considered and contacted.

Minimum Qualifications, Experience and Position Requirements

  • 3 years’ hands on experience with CNC machines, mill turn centers, metal cutting technology, modern machine tools, surface finishing machines
  • Must understand hydraulic & pneumatic circuitry
  • Electrical and mechanical background
  • Knowledge of and experience with Microsoft software

Preferred Qualifications & Experience

  • Must be fluent in English
  • Lifting up to 30 lbs.
  • Detail oriented
  • Show initiative, resourcefulness, creative thinking, and adaptability
  • Ability to perform complex tasks and to prioritize multiple projects.
  • Ability to work well under stressful conditions with critical deadlines
  • Ability to communicate throughout all levels of the organization
  • Must be able to work in a fast-paced entrepreneurial environment with changing priorities

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to lift objects weighing up to 30 lbs; stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Benefits

  • Competitive salary and benefits
Job Description

Product Quality Engineer

Overview:

Amendia is searching for a Product Quality Engineer, based in its Marietta, GA location. This position will work in cross-departmental teams to analyze customer feedback and product non-conformances. This role reports to the VP of Quality Assurance & Regulatory Affairs.

Essential Duties, Competencies & Responsibilities

  • Lead investigative efforts as they relate to product complaints and non-conformances
  • Review and facilitate disposition of product non-conformances
  • Follow up with complainants to gather information needed for MDR determinations
  • Track and trend complaints and non-conformances based on different product metrics
  • Lead corrective and preventative action activities resulting from results of investigations
  • Write and revise SOP, material specifications, verification and validation protocols, reports as necessary.
  • Specify and order QC laboratory supplies and equipment.
  • Support qualification activities for various inspection tools.
  • Review and approval of change management activities.
  • Maintain KPI for monitoring of process quality, perform analysis and interpret trends, and take action as necessary.

Minimum Qualifications, Experience and Position Requirements

  • BS Degree in a technical curriculum or equivalent industry experience preferred.
  • 0-2 years of experience
  • Ability to work in a team environment and interface effectively with cross-functional groups to define and execute overall requirements
  • Strong oral and written communication skills
  • Self-starter who can work with minimal supervision
  • Knowledge of quality control concepts desirable
  • Familiarity with ISO 13485, GDP, GMP desirable
  • Experience with Root Cause Analysis techniques
  • Familiar with operating room protocols, techniques and instruments related to spinal surgery procedures, and spinal anatomy (optional, will train as needed)

Preferred Qualifications & Experience

  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
  • Ability to work with international teams in different time zones and cultures
  • Ability to work independently and as a member of a team in a timeline-driven environment with no direct oversight
  • Being detail-oriented while having the ability to handle multiple projects/tasks
  • Demonstrate high quality standards
  • High attention to detail

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Ability to travel independently to clients; some air travel may be required.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Travel & Benefits

Competitive salary and benefit package. Travel approximately 10%

Job Description

Production Supervisor

Overview:

Amendia is searching for a Production Supervisor, based in its Marietta, GA location. The Production Supervisor role is for our second shift (3-11:30pm). Training will be done on first shift and then transfer to second shift. A minimum of 3 years’ prior supervisory experience in a medical device manufacturing company is a must. If you do not have this requirement, you will not be considered. This role reports to the VP of Manufacturing.

Essential Duties, Competencies & Responsibilities

  • Must have familiar with a variety of concepts, practices, and procedures of production and scheduling work in a manufacturing setting, relying on experience and judgment to plan and accomplish goals.
  • Must have at least 3 years’ medical device experience in a manufacturing setting.
  • Supervises the activities of production personnel engaged in all facets of the manufacturing function including but not limited to planning and coordinating production, working with personnel in plant to ensure production schedules are accomplished, identifying staffing requirements and maintaining performance records.
  • Production continuous improvement program implementation experience.
  • Interprets job specifications and recommends measures to improve production, equipment performance, and quality by identifying process bottlenecks, recommending expedites, man power adjustments, off-loading, outsourcing and reschedules to production.
  • Must have hands on approach and be skilled at educating, supporting and driving the production process to meet the department expectations and goals.
  • Use problem solving methods (DMAIC) to continuously improve quality, safety, and efficiency of current cells.
  • Support Quality management audits and respond to corrective actions as needed. Conduct or manage manufacturing assessments to ensure compliance.
  • Establish training plan to meet fluctuating customer demands.
  • Ensures compliance with OSHA regulations, workplace safety regulations and company policies and procedures.
  • Recommends and implements measures to improve production methods, equipment performance and quality of product produced.
  • Excellent listening and communication skills with employees including conducting meetings and updating employees with information. Analyze data and assist employees in resolving work problems and be hands on in assisting employees with production problems.
  • Enforce compliance to Good Manufacturing Practices, standard work and Standard Operator procedures
  • Gain knowledge of process and product within managed area.

Minimum Qualifications, Experience and Position Requirements

  • Second Shift (3-11:30pm)
  • Bachelor’s degree preferred or equivalent experience.
  • Epicor ERP systems experience is preferred.
  • Experience with CNC mills and manufacturing is preferred.
  • 3-5+ years’ experience applicable metal manufacturing practices, process improvement, problem solving.
  • Proficient in interpreting blue prints, good mathematical skills
  • Good verbal and written communication skills proficiency in various computer software and applications (Word, Excel, and ERP systems)
  • Ability to motivate and influence a Team
  • Experience in Lean Manufacturing
  • Results driven to achieve KPIs/Metrics

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to lift up to 30 lbs. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Travel & Benefits

  • Competitive salary and benefits
Job Description

Regulatory Affairs Specialist

Overview:

Amendia is searching for a Regulatory Affairs Specialist, based in its Marietta, GA location. The Regulatory Affairs Specialist performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. This role reports to the VP of Quality Assurance & Regulatory Affairs.

Essential Duties, Competencies & Responsibilities

  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Analyze product complaints and make recommendations regarding their report ability.
  • Develop or conduct employee regulatory training.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

Minimum Qualifications, Experience and Position Requirements

  • Bachelors of Science in a technical field is required, engineering preferred, Regulatory Affairs Certification (RAC) preferred
  • A minimum of 1- 3 years of Regulatory Affairs and/or Healthcare Compliance experience in medical devices is required
  • A successful track record in preparing multiple 510(k) submissions and/or PMA submissions for medical devices is required
  • Experience interacting with US FDA is required
  • Extensive international regulatory submission experience is required including translating CE mark technical documentation into 510(k) submissions

Preferred Qualifications & Experience

  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
  • Ability to work with international teams in different time zones and cultures
  • Ability to work independently and as a member of a team in a timeline-driven environment with no direct oversight
  • Being detail-oriented while having the ability to handle multiple projects/tasks
  • Demonstrate high quality standards
  • High attention to detail
  • Working knowledge of software programs including, MS Word and Excel, Project management tools (MS Project, SmartSheet), Adobe Acrobat/Nuance PDF, Google applications, and flow charting tools such as Visio or Lucidchart· Participate effectively as a team player with knowledge and expertise

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Ability to travel independently to clients; some air travel may be required.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Benefits

  • Competitive salary and benefits
  • Travel approximately 10%
Job Description

Senior Regulatory Affairs Specialist

Overview:

Amendia is searching for a Senior Regulatory Affairs Specialist, Orthobiologics, based in its Marietta, GA location. This role will perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. This role reports to the Vice President of Quality Assurance & Regulatory Affairs.

Essential Duties, Competencies & Responsibilities

  • Provide regulatory guidance for product development teams.
  • Maintain current knowledge on global regulations.
  • Maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions. Including 510(k), IDE, Technical Files and international documentation as required.
  • Analyze product complaints and assess report ability.
  • Develop or conduct employee regulatory training.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Review and approve Marketing Promotional Materials
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Participate in compliance projects to ensure ongoing compliance to standards and regulations.

Minimum Qualifications, Experience and Position Requirements

  • Bachelor's Degree, preferably in one of the following areas: Biomedical Engineering, Marketing, Healthcare, or a technical business related field
  • A minimum of 3 years’ business experience in Medical Device or Diagnostics sector
  • Experience managing orthobiologic products (synthetic, allograft, recombinant)
  • Prior experience working with healthcare professionals
  • Product launch experience
  • Demonstrated experience building strong partnerships between cross functional teams such as sales, marketing, clinical, R&D, operations, and/or other key functional stakeholders to deliver business objectives
  • Strong communication and presentation skills as well as effective planning and prioritization skills
  • Ability to influence across functions and hierarchy without authority
  • Demonstrated ability to work autonomously to deliver business results
  • Posess a documented history of receiving and managing increasingly complex assignments

Preferred Qualifications & Experience

  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively.
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
  • Ability to work with international teams in different time zones and cultures
  • Ability to work independently and as a member of a team in a timeline-driven environment with no direct oversight
  • Being detail-oriented while having the ability to handle multiple projects/tasks
  • Demonstrate high quality standards and work ethic.
  • Working knowledge of software programs including, MS Word and Excel, Project management tools (MS Project, SmartSheet), Adobe Acrobat/Nuance PDF, Google applications, and flow charting tools such as Visio or Lucidchart· Participate effectively as a team player with knowledge and expertise
  • BA/BS in a scientific discipline is required.
  • A minimum of 10+ years of Regulatory Affairs and/or Healthcare Compliance experience in medical devices is required.
  • A successful track record in preparing multiple 510(k) submissions and/or PMA submissions for medical devices is required.
  • Experience interacting with US FDA is required.
  • Extensive international regulatory submission experience is required including CE marking.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Ability to travel independently to clients; some air travel may be required.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. There is no or very limited exposure to physical risk.


Travel & Benefits

  • Up to 25% domestic and international travel may be required for this position
  • Competitive salary and benefits