Permanent position: A developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments is seeking a Senior Quality Engineer to join its team immediately! This Engineer will analyze and evaluate products to ensure quality standards are achieved and assure regulatory requirements are maintained. This person must be able to occasionally travel to local vendors to help resolve quality issues. Responsibilities for the Senior Quality Engineer
Requirements for the Senior Quality Engineer
- Assure compliance to FDA and ISO regulatory requirements; focusing on supplier/manufacturing quality, process validation/process improvement
- Perform hazard and risk analyses (PFMEA) for new and existing processes
- Support the coordinated integration of new manufacturing processes and suppliers
- Generate process/product quality information in the form of Critical to Quality (CTQ) indices
- BS Mechanical Engineering preferred; ASQ CQA, CQE or CSSBB preferred
- 5 - 7 years Medical Device experience in a Quality Engineering role, supplier auditing, and supplier management in an FDA-related manufacturing environment, with a history of successful participation in process and supplier development, validation and improvement.
- Strong working knowledge of 21 CFR Part 820 and ISO 13485.
- Machining, casting/forging experience a plus; orthopedic experience preferred.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.