NextPhase Medical Devices LLC is a fast-growing, engineering design and contract manufacturer of single-use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, Waldwick, NJ, and Tijuana, Mexico.
Based in our Mansfield, MA facility, the Quality Engineer will help establish and maintain a corporate quality system and provide quality assurance support to medical device development and validation efforts. Along with management and the engineering team, the Quality Engineer will be responsible for various aspects of implementing and maintaining ISO 13485 and FDA GMP quality system procedures. The Quality Control Engineer will participate in product development teams to provide design control quality assurance functions.
Other Responsibilities include:
- Perform internal quality and design audits.
- Participate in medical product risk analysis.
- Plan, develop, and execute verification and validating testing for products under development.
- Participate in technical review of design input specifications and design documentation for new
medical devices. - Assist corporate management in implementing and maintaining a quality system that is
compliant with ISO 13485 and FDA quality system regulation requirements.
Skills & Experience Required:
- Bachelor of Science degree in Engineering or equivalent experience.
- 4+ years in medical device quality assurance.
- ASQC Certification desired.
- A working understanding of FDA Quality Systems regulations, EU Active Implantables and Medical Device Directives, and ISO-13485 principles.
- Working knowledge of IEC 60601 medical device safety standards and IEEE software quality standards is preferred.