Sr. QC Manager (Medical Devices)

Location: Hybrid role based in Waltham, Massachusetts, supporting manufacturing facilities in Waltham, Norwood, and Billerica, Massachusetts

Salary: $150,000–$170,000 per year

Company

hirify.global develops biotechnology, clinical, point-of-care, and in vitro diagnostic instruments, consumables, and reagents for drug development and patient care.

What you will do

• Lead Quality Control operations across multiple U.S. manufacturing and distribution sites.
• Define enterprise-wide QC strategies, procedures, testing methodologies, inspection standards, and performance metrics.
• Build and mentor QC teams while promoting accountability, compliance, and continuous improvement.
• Establish systems for collecting, monitoring, analyzing, and reporting product quality and manufacturing performance data.
• Lead root-cause investigations and use statistical tools to address defects, process shifts, nonconformances, complaints, and performance gaps.
• Partner with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Supplier Quality, Engineering, and Distribution teams to improve quality and manufacturing capability.

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 and process trend analysis, nonconformance reduction, risk management, quality reporting, and multi-site manufacturing.
• Experience with process and equipment validation, including IQ, OQ, and PQ documentation, plus Quality Plans and Quality Control Plans.
• Strong project management, leadership, team development, and data analysis skills.

Nice to have

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

Culture & Benefits

• Hybrid and flexible work arrangements.
• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• On-site marketplace, snacks, and cafeteria benefits at selected Massachusetts and Maine offices.