Passy Muir, Inc. has an opening to fill the medical device Regulatory Affairs, Quality Assurance Specialist position. The RA/QA Specialist is responsible for assisting the RA/QA Manager in maintaining and supporting the Quality Management System to comply with relevant national and international standards and regulations. Candidates must be able to function well in a fast-paced, multi-task office environment. Please see below for details pertaining to the position. Candidate must have a stable employment history and relevant experience. No calls, please.
- Proactively develops and maintains the company’s Quality Management System in accordance with regulatory and corporate requirements.
- Works closely with the production facility to ensure adequate quality controls are undertaken.
- Assists with verification activities.
- Assists with customer complaints/CAPA system.
- Tracking and trending of out-of-specification results, failure investigation, deviations, change controls (equipment and document) and complaints.
- Approval and release of Quality Records, Device History Records, Master Labels and Device Master Records.
- Monitoring and verification of qualification and validation processes to ensure compliance with written protocols and regulatory requirements.
- Development of risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
- Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions.
- Development and drafting of documents and procedures pertinent to Quality Assurance activities and functions.
- Supports new product development, risk analysis and launch processes, and manage QA participation in new product development.
- Participates in the Corrective and Preventive Action System, Non-conformance System, internal and external audits, labeling review and regulatory submissions globally, as well as document changes within the Document Control System.
- Minimum 5 years’ experience in medical device manufacturing
- Experience with ISO 13485 / 21 CFR 820 required
- Experience with ISO 13485:2016 strongly preferred
- Knowledge of EU MDR preferred
- Experience with Class II FDA 510(k) submissions strongly preferred
- Risk management procedure and project management experience necessary
- Strong communication & documentation skills necessary
- Flexibility and adaptability
- Ability to work in a team environment, strong organization and leadership skills
- ASQ Certification for Certified Quality Manager or Certified Quality Auditor is a plus
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.
Salary commensurate with experience.
Job Type: Full-time