Sr. QC Manager

About the role

The Sr. Quality Control Manager is responsible for leading and scaling Quality Control (QC) operations across multiple U.S. manufacturing facilities in Waltham, Norwood, and Billerica, Massachusetts, supporting the production of biotechnology and clinical systems, including point-of-care (POC) and in vitro diagnostic (IVD) medical devices, consumables, and reagents. This role ensures product quality, regulatory compliance, and operational excellence throughout the manufacturing lifecycle, with a strong emphasis on data-driven quality management, statistical monitoring, and continuous improvement.

Responsibilities

• Lead Quality Control functions across multiple manufacturing and distribution sites within the United States.
• Establish and maintain enterprise-wide QC strategies, policies, procedures, and performance metrics.
• Build, develop, and mentor high-performing Quality Control teams while fostering a culture of accountability, compliance, and continuous improvement.
• Ensure consistency of QC practices, testing methodologies, and inspection standards across all facilities.
• Drive operational excellence initiatives that improve product quality, efficiency, and scalability.
• Establish robust systems for collecting, monitoring, analyzing, and reporting product quality and manufacturing performance data.
• Proactively identify trends, emerging product risks, recurring defects, process shifts, and performance gaps to support continuous improvement.
• 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 the management of 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 the effective use of procedures, processes, quality engineering tools, and data analysis.

Requirements

• 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 activities, 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.
• Bachelor's degree or higher in a technical discipline, preferably within Life Sciences, Chemistry, Medical Technology, or a related field.
• 5–10 years of Quality Control management experience within an FDA-regulated medical device, IVD, or reagent manufacturing environment.
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Green Belt Six Sigma certification preferred.