We are currently recruiting for Quality Manager. This position is responsible for providing quality assurance oversight of the medical device function focused on aesthetic products developed in-house and in collaboration with partners and CMOs.
Essential Roles and Responsibilities:
- Manage the Medical Device Quality Management function ensuring compliance to all applicable medical device regulations.
- Manage a team of Quality Associates in support medical device QMS maintenance and new product development.
- Provide guidance and participate where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.
- Provides technical support to engineers and regulatory team for technical filings and updates.
- Interact with partners and contract organizations to ensure timely completion of project milestones.
- Demonstrated success running lean, efficient and effective quality systems for regulated medical devices
- Project management skills and proficiency and analyzing and interpreting test data
- Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 & 2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, and Current Good Manufacturing Practices (CGMP).
- Approximately 20% travel.
- Perform other duties as assigned.
Job Related Qualifications/Skills:
- Any combination of education and experience equivalent to a bachelor’s degree in Science, Business, or Engineering required; advanced degree preferred.
- 5+ years of experience in Quality Assurance and/or Regulatory Affairs for regulated medical device products
- 3+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485 standards