Senior Quality Engineer (Medical Devices)

Location: Hybrid schedule in Billerica, Massachusetts, with on-site work 4–5 days per week

Salary: $125,000–$135,000 per year

Company

hirify.global develops instruments and in vitro diagnostic solutions for biopharmaceutical and clinical markets, with FDA-registered and ISO-certified manufacturing operations.

What you will do

• Provide quality engineering oversight across design transfer, incoming inspection, production, field returns, quality systems, and data monitoring.
• Prepare and review Engineering Change Orders, Manufacturing Variances, operating procedures, and operating instructions.
• Maintain Quality Control Plans and PFMEAs for new and existing products.
• Design database queries and reports, analyze quality trends, and present conclusions to senior management.
• Generate and review IQ, OQ, and PQ validation protocols and reports.
• Lead root-cause investigations, corrective actions, DHR reviews, and process improvement initiatives.

Requirements

• Bachelor’s degree or higher in engineering or a technical science, or equivalent experience.
• 8+ years of Quality Engineering experience in FDA-regulated medical device, IVD, or reagent manufacturing.
• Strong knowledge of ISO 13485, ISO 14971, MDSAP, and FDA 21 CFR Part 820.
• Experience with PFMEAs, risk analysis, validation plans, internal audits, sampling plans, statistical analysis, and SPC.
• Knowledge of manufacturing processes, inspection methods, quality data trending, and technical documentation.
• Proficiency with Microsoft Word, Excel, Access, and statistical software such as Minitab.

Nice to have

• Experience with MasterControl or Power BI.
• ASQ certification as a Quality Engineer or Medical Device Auditor.
• Experience validating manufacturing equipment, processes, or test methods.

Culture & Benefits

• Hybrid and flexible work arrangements with substantial on-site presence.
• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Company cafeterias, lunch and snack programs, engagement events, and a collaborative work environment.