Quality Systems Specialist (Complaint, Medical Devices, ISO 13485, 21 CFR 820) in Lexington, MA at Apex Life Sciences

Date Posted: 10/30/2018

Job Snapshot

Job Description

 Quality System Specialist (Complaint Handling, ISO 13485, MED. DEVICE, 21 CFR 820, CAPA)

The QUALITY SYSTEM SPECIALIST will provide support to a TOP CLIENT in the Greenwich CT area. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) Medical Device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards. Self-motivated, independent Quality Compliance Lead to handle complaints and FDA Medical Device regulations; 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807.


  • Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records
  • Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records
  • Coordinate all Mandatory Field Notifications and Engineering Change Orders, take appropriate action and maintain all records
  • Perform Internal Audits and External Supplier Audits
  • Prepare Management Review Meeting presentations


  • Bachelor's (BS) degree and 5+ yrs. experience within the Med. Devices Quality/ Regulatory space
  • 5+ years of hands-on experience performing Quality System support activities in a U.S. FDA regulated environment; independently managing complaint handling processes and enforcing compliance with related regulatory guidelines.
  • Expertise with U.S. FDA Medical Device regulations; 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807.
  • Deep knowledge of International Medical Device Standard requirements; ISO 13485/ ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations.

FOR IMMEDIATE CONSIDERATION please e-mail a copy of your resume to Eric Anderson at eanderson@apexlifesciences.com .


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.