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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

Document Control and Training Manager

Overview:

Amendia is searching for a Document Control and Training Manager, based in its Marietta, GA location. The individual will be responsible for managing company document systems and training on quality procedures to ensure compliance with FDA regulations and ISO 13485 standards. This role reports to V.P. of Quality Assurance & Regulatory Affairs.

Essential Duties, Competencies & Responsibilities

  • Management of quality assurance group in regards to:
    • Organization and maintenance of Amendia document control systems
    • Routing and tracking of documents for approval
    • Release of documents and distribution of copies
    • Ensure current document revisions are available
    • Identification of obsolete documents and removal
    • Scanning and archiving quality records
    • Label modifications
    • Review and edit Quality Management System policies and procedures
  • Ensure training compliance to quality system documentation
  • Track and trend quality metrics in regards to documentation approvals and training
  • Ensure data integrity between eQMS and ERP systems

Minimum Qualifications, Experience and Position Requirements

  • A minimum of a Bachelor’s Degree or equivalent
  • Knowledge of FDA quality system and ISO 13485 quality systems for medical devices
  • Knowledge of good documentation practice (GDP) and good manufacturing practice (GMP).
  • Customer driven with sense of urgency/priority in responding to customer’s needs
  • Ability to work under pressure while completing assignments.

Preferred Qualifications

  • 4-6 years of document control experience (medical device industry preferred)
  • Experience managing ERP, eQMS and software validations in a regulated environment 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 twist, grip, finger, handle, or feel; reach with hands and arms; and talk or hear for extended periods. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.


Work Environment and Environmental Conditions

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

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

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