Quality Engineer

Pragmatic; Burlington (MA); Hybrid; USD 100,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Profit sharing

One remote day per week

Job summary

Pragmatic is seeking a Quality Engineer II for a Class III implantable device program in Burlington, MA. You will own complaint investigations, CAPAs, and support V&V and design controls across product lifecycle.

The candidate should have 18 months to 3.5 years in medical device quality, a bachelor’s in engineering, and hands-on ISO 13485/14971 and 21 CFR 820 experience. On-site four days a week, one day from home, with a competitive base salary.

Qualifications

• 18 months to 3.5 years in medical device quality
• Exposure to V&V or design assurance
• Post-market or complaints experience welcomed

Responsibilities

• Own complaint investigations and CAPAs for a commercial Class III implant
• Support V&V and design controls on new product development
• Build and run inspection protocols for materials and finished product

Skills

Medical device quality

V&V exposure

Design controls

Root cause analysis

Education

Bachelor's in engineering

Job description

Class III Implantable Devices Burlington, MA. On site four days a week, one day from home.

Most early-career quality engineers get one narrow slice of a big company's quality system. This role gives you the whole lifecycle.

Our client builds implantable devices on a proprietary hydrogel platform.

• Track record: their lead product, a Class III surgical sealant, went from program start to PMA approval in about three and a half years, roughly half the industry norm.
• Latest approval: a second product from the same platform received FDA PMA approval this autumn.
• New headquarters: the company is now moving into a much larger HQ with manufacturing and labs in Burlington, just off Route 3 and I-95.

The team is small, so the work is broad. You could be on a nonconformance on Monday and a design verification on Tuesday.

Where it leads. The company is growing fast, and the role grows with it, with real room to progress. They develop and promote their own people. I've partnered with this quality team for several years, and in that time no one has left.

About the Role

This Quality Engineer II role works across the full lifecycle of Class III implantable devices on a proprietary hydrogel platform, supporting both commercial products and new product development in a fast-growing, small-team environment.

Responsibilities

• Own complaint investigations and CAPAs for a commercial Class III implant, from root cause to closure
• Support V&V and design controls on new product development programs
• Build and run inspection protocols for raw materials, in-process and finished product
• Work hands-on with manufacturing and R&D to ISO 13485, ISO 14971 and 21 CFR 820, as the company brings its products into the new facility

Qualifications

• A bachelor's in engineering or a related science.

Required Skillls

• 18 months to 3.5 years in medical device quality. Combination products or other FDA-regulated device work also fits. Recently promoted QE IIs and strong QE Is both fit.
• Some design assurance, V&V or risk management exposure. Co-ops and internships count.
• Post-market or complaints engineers who want more design work are very welcome.

Preferred Skills

• Nice to have: implantables, polymers or hydrogels, process validation.

Pay range and compensation package

• The package: $100,000-$110,000 base, plus an annual bonus and profit sharing.
• On site four days a week; no visa sponsorship.