Hiring: Sr. QC Manager Company: Nova Biomedical Location: Waltham, MA Job Posted Time: 2026-09-10 10:18:46 Employment Type: Hybrid Target Skills & Keywords : R, Regulatory Compliance About the job Experience: •10+ years of Quality Control management experience within an FDA-regulated medical device, IVD, or reagent manufacturing environment. Required Skills: •The ideal candidate will be a collaborative leader who partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and Operations leadership to drive quality objectives, business expansion, and commercialization goals. •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. Qualifications: •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. •Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820. •Strong project management, leadership, and team development skills. •ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Green Belt Six Sigma certification preferred. •Comfort with working at a computer for extended periods. •Capacity to lift and carry up to [25–50] pounds as required •Able to communicate effectively via phone, video, and written communication. Compensation: •$150,000 - $170,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!