We are looking for a Quality Engineer in our Billerica, MA facility, first shift! Great company, competitive salary and benefits.
The client is an established ISO 13485 registered company and has been manufacturing machined and finished assembly products for the medical industry for over 30 years.
Summary of Position
The Quality Engineer will support new product development as well as sustaining product. The ideal candidate will have experience in an ISO and FDA QSR regulated environment. Responsibilities include:
- Perform validations (IQ/OQ/PQ) on equipment and processes
- ECO generation and implementation on Procedures and WI
- CAPA generation and implementation
- Assist with MRB dispositions
- Work with engineering regarding customer risk management activities (PPAP programs, PFMEA’s, Control Plans, etc.)
- Identify process problems and implement corrective actions
- Calibration maintenance
- Bachelor of Science in Engineering required
- 3-5 years of medical device experience required.
- Lean manufacturing and Kaizen skills are a plus
- Regulatory experience a plus
- CMM experience a plus