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RA/QA Specialist

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.

Job Details:

  • 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.

 

Job Requirements:

  • 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