Sr. QC Manager

Nova Biomedical • Waltham, MA

2d • Hybrid

About The Position

The Sr. Quality Control Manager leads and scales Quality Control operations across Nova Biomedical’s U.S. manufacturing facilities in Waltham, Norwood, and Billerica, Massachusetts. The role supports production of biotechnology and clinical systems, including point-of-care (POC) and in vitro diagnostic (IVD) medical devices, consumables, and reagents. It is accountable for product quality, regulatory compliance, and operational excellence across the manufacturing lifecycle, with an emphasis on data-driven quality management, statistical monitoring, and continuous improvement.

The manager develops and executes QC strategies that support FDA medical device requirements, MDSAP, IVDR, ISO 13485, ISO 14971, and other applicable standards while enabling organizational growth. The role partners with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Operations leadership, and related teams to advance quality objectives, business expansion, and commercialization.

Requirements

• Bachelor's degree or higher in a technical discipline, preferably 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 working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations, including 21 CFR Part 820.
• Experience developing product and process trend analyses, nonconformance reduction programs, risk reduction initiatives, cost-containment efforts, and executive-level quality reporting.
• Experience applying product lifecycle risk management principles for IVD medical devices.
• Experience linking QC trends, nonconformances, complaint investigations, and manufacturing performance data to product risk management activities.
• Experience with process and equipment validation, including authoring and reviewing IQ, OQ, and PQ documentation.
• Experience authoring Quality Plans and Quality Control Plans.
• Experience supporting multi-site manufacturing operations.
• Strong project management, leadership, and team development skills.

Nice To Haves

• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Green Belt Six Sigma certification.

Responsibilities

• Lead Quality Control functions across multiple manufacturing and distribution sites in the United States.
• Establish and maintain enterprise-wide QC strategies, policies, procedures, and performance metrics.
• Build, develop, and mentor Quality Control teams and foster accountability, compliance, and continuous improvement.
• Ensure consistent QC practices, testing methodologies, and inspection standards across facilities.
• Drive operational excellence initiatives to improve product quality, efficiency, and scalability.
• Establish systems to collect, monitor, analyze, and report product quality and manufacturing performance data.
• Identify trends, emerging product risks, recurring defects, process shifts, and performance gaps.
• Lead root-cause investigations using structured problem-solving methodologies and statistical tools.
• Analyze quality, yield, reliability, complaint, nonconformance, and production-output data to improve product performance and manufacturing capability.
• Ensure compliance with FDA, MDSAP, IVDR, ISO, and other applicable regulatory requirements and harmonized standards.
• Oversee documentation, records, test reports, deviations, investigations, CAPAs, and quality metrics.
• Collaborate with R&D, Supplier Quality, Incoming Inspection, Manufacturing, Manufacturing Engineering, Finished Goods, and Distribution teams to drive quality improvements.
• Support engineering and manufacturing quality initiatives through procedures, processes, quality engineering tools, and data analysis.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match.
• Bonus program.
• Generous paid time off and paid holidays.
• Tuition reimbursement.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks at the Norwood, Billerica, and Westbrook offices.
• Company-subsidized cafeteria at the Waltham office.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior