- The Quality & Engineering Manager will maintain and drive improvements to all aspects of site quality & process engineering planning.
- Ensure consistent application of plans and programs to drive compliance for all applicable governmental regulations. Oversee all quality related communications and training requirements for all site employees.
- Responsible for maintenance of all manufacturing process documentation. Oversee the Corrective Action / Preventive Action (CAPA) activities, supplier corrective actions, and quality engineering.
- Responsible for leading the implementation of new products into manufacturing. Relocation provided. $100K-$140K.
- The Quality & Engineering Manager will have a BS or MS degree with an engineering major.
- A Quality certification is a strong plus. 7+ years of managerial experience in a medical device / equipment manufacturing environment.
- Leadership experience with FDA’s Quality System Regulations, ISO9001, ISO13485, Medical Device Directive (MDD) and/or other international quality systems requirements.
- Must be legally eligible to work in the U.S. without sponsorship.