Senior Quality Assurance Engineer (Medical Devices)

Location: Onsite in Acton, Massachusetts, United States; office, plant, and lab work required

Annual base salary: $87,300–$130,950, plus potential incentive compensation

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other subcutaneous drug delivery solutions.

What you will do

• Provide daily quality engineering support to manufacturing operations and represent quality on production-related issues.
• Lead investigations into nonconformances, deviations, quality events, and lot qualification issues using structured root cause analysis.
• Lead or support CAPAs, risk assessments, corrective and preventive actions, and cross-functional process improvement initiatives.
• Support process and test method validations using FMEA, IQ, OQ, PQ, control plans, SPC, DOE, Cpk, Cp, and DMAIC.
• Write and review validation protocols, reports, and gauge R&R documentation.
• Support material review boards, product releases, audits, regulatory inspections, and mentoring of junior quality engineers.

Requirements

• Bachelor’s degree in engineering or an equivalent combination of education and experience.
• At least 5 years of quality engineering experience, including at least 3 years supporting medical device manufacturing.
• Experience leading nonconformance investigations, CAPAs, and root cause analyses in a production environment.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 quality and risk management requirements.
• Strong analytical, troubleshooting, technical writing, communication, and prioritization skills.
• Experience analyzing complex data with Excel, Minitab, or comparable statistical software.

Nice to have

• ASQ Certified Quality Engineer certification.
• ISO 13485 auditor training certification.
• Experience supporting FDA inspections, MDSAP audits, and notified body audits.

Culture & Benefits

• Full-time onsite work in a manufacturing, office, and laboratory environment.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.