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Sr. Manager - QA in Sandy Springs, SC ,  at Arthrex

Date Posted: 4/20/2018

Job Snapshot

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Job Description

Requisition ID:
Sr. Manager - QA
Arthrex Manufacturing Inc
AMI South Carolina

This position will be located at the Arthrex manufacturing facility in Sandy Springs, SC.  The person who fills this role will work at the Arthrex manufacturing facility in Ave Maria, FL to start and must be able to travel between/work at both the Ave Maria, FL facility and the Sandy Springs, SC facility as needed.

Main Objective:

Responsible for ensuring that the Manufacturing Quality System is effectively established, deployed, maintained, and continually improved.  Works closely with the Director of Operations and the QA Director - AMI to drive and maintain world class manufacturing operations and quality outcomes. Develops and mentors QA leaders and staff.  Monitors and reports on the performance of the quality system to management and establishes the format and frequency of these reports.

Essential Duties and Responsibilities:

  • Has overall leadership responsibility for the Manufacturing Quality Assurance department, including

    Manufacturing Quality Engineering, Sterilization, Quality Control, Validation, Calibration, and other related activities as assigned.

  • Responsible for maintaining a Manufacturing Quality System that is in compliance with worldwide medical device regulations, including FDA Quality System Regulations and European Medical Device Directives.
  • Responsible for Manufacturing QA/QC support, inspection efficiency, supplier technical QA relationships, team training and documentation.
  • Manage the operating budgets for Manufacturing Quality Assurance Department.
  • Participate in the design control process as it relates to the transfer of new designs to manufacturing, and the maintenance of existing designs.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • Bachelor’s degree in an Engineering or related discipline required
  • 10+ years experience in the technical and leadership aspects of Quality Assurance and Quality Control is required.
  • Extensive experience in Quality Assurance activities within a regulated, Medical Device, and/or GMP/ISO compliant organization is desired. Experience working with International regulatory bodies and with the FDA is desired.
  • Direct experience as a Manager with leadership / supervisory responsibilities (>25 people) in a manufacturing environment required (a minimum of 10 years relevant management experience required).

Knowledge and Skill Requirements/Specialized Courses and/or Training:

In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.

Ability to manage a diverse department, and develop personnel in accordance with company objectives. Training and or certification in Lean/Six Sigma is desired. ASQ Manager of Quality & Organizational Excellence Certification is a plus.

Machine, Tools, and/or Equipment Skills:

Personal Computer skills including but not limited to Microsoft Office, Pilgrim Smart Solve, SAP, and Agile are desired, as well as a general understanding of precision test and measurement equipment.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions and engineering drawings in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

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 the 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 talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


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