Quality Engineer

Quality Engineer II Bedford, Massachusetts. On site four days a week, one day from home.

Most quality engineers spend years on one product line, owning a narrow slice of somebody else's quality system. This role is the opposite of that.

We design and build implantable medical devices from a proprietary hydrogel platform. Our lead product is a Class III implant that went from program start to PMA approval in about three and a half years, against an industry norm closer to seven. It has been on the market since 2023, and there are three more products in the portfolio behind it.

The technology behind the platform has launched more than ten medical device companies, created over $4 billion in value, and helped more than five million patients.

The team is small, which is the actual selling point. A Quality Engineer II here does incoming inspection on Monday and design controls for a new program on Tuesday. That range is the job.

• Building and maintaining inspection protocols and quality standards for raw materials and manufacturing processes, then running incoming, in process and final inspection against them.
• Giving real time quality support on the manufacturing floor: nonconforming material investigation and disposition, document review, root cause analysis and calibration control.
• Supporting verification and validation for new product development and sustaining programs, alongside design controls, qualifications and design change.
• Running quality system activity across CAPA, nonconformance reporting and complaint handling, to ISO 13485, FDA QMSR and 21 CFR Part 820.
• Tracking and reporting the quality metrics that drive continuous improvement, and partnering with manufacturing and R&D to keep process controls robust.

• Two to four years in a regulated environment. Medical device, pharmaceutical, biotech or diagnostics all count.
• A working understanding of ISO 13485 and FDA QMSR or 21 CFR Part 820.
• A bachelor's degree in engineering or a scientific discipline, or equivalent experience.
• The organization and attention to detail that quality documentation demands, and the judgment to know which problems need escalating.
• Comfort working with minimal supervision across manufacturing, R&D and regulatory. In a team this size, nobody is going to hand you a swim lane.

• Class III, PMA or combination product exposure.
• Implantables, sealants, hemostats or hydrogel materials.

A PMA approved device already selling, and several more in active development. You get the commercial side and the development side at the same time, on a platform with a long record of getting products approved and companies exited. That is a different proposition from a large employer, and it is a hard one to find in a QE II role.