Supplier Quality Engineering Manager (Medical Devices)

Location: Hybrid in Waltham, Massachusetts, United States. Monday to Friday, 8:30 AM–5:00 PM.

Salary: $130,000–$150,000 per year.

Company

hirify.global develops diagnostic and biotechnology instruments for drug development, clinical workflows, and patient care, with FDA-registered and ISO-certified manufacturing.

What you will do

• Lead and develop a team of Supplier Quality Engineers across supplier qualification, process validation, design transfer, NPI, manufacturing, and sustaining operations.
• Partner with R&D, Manufacturing Engineering, Operations, and suppliers to qualify processes, components, and critical materials.
• Drive APQP, risk-based qualification strategies, IQ/OQ/PQ activities, process capability studies, and manufacturing readiness assessments.
• Lead supplier-related NCMR investigations, SCARs, root cause analysis, corrective actions, and effectiveness reviews.
• Analyze supplier quality data to reduce defects, improve process capability, and strengthen supply chain performance.
• Conduct supplier technical assessments and serve as the subject matter expert during internal, regulatory, ISO 13485, MDSAP, and IVDR audits.

Requirements

• Bachelor’s degree in engineering, such as mechanical, manufacturing, industrial, biomedical, or chemical engineering.
• At least 7 years of progressively responsible engineering experience in supplier quality, manufacturing, quality, process engineering, or a related role within a regulated industry.
• Previous people leadership or engineering management experience.
• Experience with manufacturing processes, process controls, supplier and process qualification, validation, design transfer, scale-up, and NPI.
• Knowledge of SPC, process capability analysis, DOE, sampling plans, trend analysis, 8D, DMAIC, Fishbone Analysis, and Five Whys.
• Knowledge of ISO 14971, ISO 13485, MDSAP, FDA Quality System Regulation, and medical device or life sciences supplier quality requirements.

Culture & Benefits

• Hybrid and flexible work arrangements.
• Medical, dental, and vision coverage with a competitive 401k company match.
• Bonus program, paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Collaborative culture based on customer centricity, ingenuity, ownership, accountability, collaboration, and integrity.
• Ability to work at a desk for extended periods and carry up to 25 pounds.