Senior Quality Engineer (Medical Device/IVD)

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

Salary: $110,000–$130,000 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 oversight and continuous improvement for quality systems, including audits, document control, change management, CAPA, validation, and quality records.
• Lead quality initiatives across design transfer, inspection, production, data monitoring, and new product introduction.
• Prepare and review Engineering Change Orders, Manufacturing Variances, Quality Control Plans, and PFMEAs.
• Develop and validate database queries and reports, analyze trends, and draw conclusions from production and quality data.
• Generate and review IQ, OQ, and PQ validation protocols and reports, maintaining validation files and logs.
• Support external audits, root-cause investigations, corrective actions, and quality management reviews while mentoring quality engineers.

Requirements

• Bachelor's degree or higher in engineering or a technical science.
• 7+ years of medical device or IVD quality engineering experience, or 4+ years as a Senior Quality Engineer in an FDA-regulated manufacturing environment.
• Knowledge of ISO 9001, ISO 13485, ISO 14971, IVDR, and FDA-regulated quality requirements.
• Experience with MS Word, Excel, Access, and statistical software such as Minitab.
• Strong communication, analytical, prioritization, multitasking, judgment, and technical-document interpretation skills.
• Ability to work in a laboratory environment, use PPE, handle laboratory equipment, and lift up to 25 pounds.

Nice to have

• Experience with MasterControl or Power BI.
• Auditing experience or certification.

Culture & Benefits

• Flexible medical, dental, and vision coverage.
• 401(k) company match and bonus program.
• Generous paid time off, paid holidays, and tuition reimbursement.
• Professional development, engagement, and company events.
• Hybrid and flexible work arrangements with on-site office amenities.