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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

Quality Assurance Specialist

Overview:

Amendia is searching for a Quality Assurance Specialist, based in its Marietta, GA location. The Quality Assurance Specialist is responsible for supporting quality systems to advance the development and manufacture of medical devices; including data and document review and approval as well as assistance with internal and external audit. This role reports to the Document Control & Training Manager.

Essential Duties, Competencies & Responsibilities

  • Review and audit DHR documentation for final product release
  • Trending and analysis of quality data
  • Maintain and coordinate Non-conforming product process
  • Support receiving, in-process and final product inspection
  • Support calibration and preventative maintenance process
  • Help with internal and supplier audits
  • Support maintenance of files

Minimum Qualifications, Experience and Position Requirements

  • 2-3 years of Quality experience
  • Experience in Medical Device industry preferred
  • BS degree in related field
  • Great attention to detail
  • General proficiency of Microsoft Excel and Microsoft Word
  • Strong verbal and written communication skills
  • Strong understanding of ISO 13485 and FDA regulation. Lead auditor certification a plus
  • Problem solving and problem analysis

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. Working conditions are normal for an office and manufacturing environment. Work may involve lifting of materials and product up to 30 pounds. Working in this environment may require the use of safety equipment which includes but is not limited to eye safety glasses, hearing protectors, and work boots.


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

Receptionist/Customer Service Support

Overview:

Spinal Elements is searching for a Receptionist needed for front office of our Carlsbad, CA location. The position will also be support person for the Customer Service department and have the ability to do all the tasks performed by Customer Service as well as answer multi-line phone, greet customers, and provide internal support for other departments. This role reports to the Customer Service Supervisor.

Essential Duties, Competencies & Responsibilities

Main Job Tasks and Responsibilities

  • Inventory tracking and reconciliation, returns, invoicing, processing orders, complaints, working with regional accounts, Regional Managers, CFO, Regulatory Department, Product Managers and other Customer Service Representatives on a daily basis.
  • Must have the ability to work in a fast-paced office and to serve customers in a medical device environment.
  • Technical knowledge of products and multi-tasking a must.
  • Knowledge of Excel, Quick books, and Microsoft Outlook preferred.
  • Must have customer service oriented personality and proactive attitude toward problem solving, catering to customers, and working with team members.
  • Will train the right person.

Education and Experience

  • College Degree Preferred.
  • Excellent organizational, communication, customer service and team oriented skills a must.

Position Type/Expected Hours of Work

This is a Full-time position. US Work Authorization required. Days and hours of work are Monday through Friday; 8:30 AM to 5:30 PM


Physical Demands

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

This job operates in an office setting.


Supervisory Responsibility

This position is not supervisory role.


Travel

This position requires no travel.

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