Responsibilities
- The Quality Engineering Manager has overall leadership responsibility for the Manufacturing Quality Assurance department, including Manufacturing Quality Engineering, QA Technicians, and other related activities as assigned.
- Responsible for maintaining a manufacturing quality system that is in compliance with worldwide medical device regulations, including FDA Quality System Regulations and European Medical Device Directives.
- Responsible for manufacturing QA support, inspection efficiency, supplier technical QA relationships, team training and documentation.
- Manage the operating budget for manufacturing quality assurance department.
- Relocation provided. $120K-$140K.
Requirements
- The Quality Engineering Manager will have a BS degree with an engineering major – mandatory.
- Minimum 10 years of QA experience required, medical device manufacturing or similar FDA regulated industry.
- 3 years of direct management/supervisory experience required.
- Knowledge of testing equipment and applicable national standards relating to testing (i.e. ASTM standards, etc.). Familiarity in operating all test and inspection equipment used in Quality. Familiarity with applicable federal, military, FDA, ISO and EN specifications.
- Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.