Sr. QC Manager (Medical Devices)

TL;DR

Sr. QC Manager (Medical Devices): Leading and scaling quality control operations for biotechnology, point-of-care, and in vitro diagnostic medical devices across multiple U.S. manufacturing facilities with an accent on regulatory compliance, statistical monitoring, and continuous improvement. Focus on building enterprise-wide QC strategies, linking manufacturing data to product risk management, and solving complex quality and scalability challenges across sites.

Location: Waltham, Massachusetts, with travel between U.S. manufacturing facilities as needed; hybrid and flexible work arrangements are available.

Salary: $150,000–$170,000 per year

Company

hirify.global develops biotechnology and in vitro diagnostic instrumentation, consumables, reagents, and scientific solutions for drug development and patient care.

What you will do

• Lead Quality Control functions across multiple U.S. manufacturing and distribution sites.
• Establish enterprise-wide QC strategies, procedures, testing standards, and performance metrics.
• Build, develop, and mentor high-performing QC teams while promoting accountability and continuous improvement.
• Monitor and analyze quality, yield, reliability, complaint, nonconformance, and production data to identify risks and performance gaps.
• Lead root cause investigations, CAPAs, trend analyses, validation activities, and quality improvement initiatives.
• Partner with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Supplier Quality, and Operations teams to support compliance and commercialization.

Requirements

• Bachelor’s degree or higher in a technical discipline such as Life Sciences, Chemistry, Medical Technology, or a related field.
• 5–10 years of Quality Control management experience in an FDA-regulated medical device, IVD, or reagent manufacturing environment.
• Strong knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, FDA regulations, and 21 CFR Part 820.
• Experience with product lifecycle risk management, trend analysis, nonconformance reduction, complaint investigations, and executive-level quality reporting.
• Experience with IQ, OQ, and PQ validation documentation, Quality Plans, Quality Control Plans, and multi-site manufacturing operations.
• Strong project management, leadership, team development, and data analysis skills.

Nice to have

• ASQ CMQ/OE, CQE, or Green Belt Six Sigma certification.

Culture & Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match and bonus program.
• Generous paid time off, paid holidays, and tuition reimbursement.
• Professional development opportunities, engagement programs, and company events.
• On-site cafeteria and marketplace services at Massachusetts offices.
• Equal opportunity employer committed to a diverse and inclusive workforce.