Quality Assurance Engineer (Medical Devices)

Location: Onsite in Acton, Massachusetts, United States; office, plant, or lab presence is required

Annual base salary: $70,400–$105,650, plus potential incentive compensation.

Company

hirify.global develops medical devices for diabetes management and other therapeutic applications, including the Omnipod product platform.

What you will do

• Provide daily quality engineering support to manufacturing operations and production-related issue resolution.
• Investigate deviations, nonconformances, and lot qualification issues using structured root cause analysis.
• Participate in Material Review Board activities and support disposition decisions.
• Lead or support CAPAs, corrective and preventive actions, risk assessments, and continuous improvement projects.
• Support process and test method validations using FMEA, control plans, SPC, DOE, Cp/Cpk, DMAIC, and related quality tools.
• Prepare and review validation protocols, reports, gauge R&R analyses, manufacturing documentation, audits, and product release activities.

Requirements

• Bachelor’s degree in engineering or an equivalent combination of education and experience.
• 3–5 years of quality engineering experience, including at least 2 years supporting medical device manufacturing.
• Experience leading nonconformance investigations, CAPAs, and root cause analyses in a production environment.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 risk management.
• Strong analytical, troubleshooting, decision-making, technical writing, and communication skills.
• Ability to work onsite in the Acton office, plant, or laboratory.

Nice to have

• ASQ Certified Quality Engineer certification.
• ISO 13485 auditor training certification.
• Experience supporting FDA inspections, MDSAP audits, and notified body audits.
• Experience analyzing complex data and test results with Excel, Minitab, or other statistical software.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Cross-functional collaboration with manufacturing, engineering, operations, and quality teams.