Sr. QC Manager

novabio; Waltham (MA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Flexible medical, dental, & vision

Hybrid and flexible work arrangements

Tuition reimbursement

Job summary

Nova Biomedical is seeking a Sr. Quality Control Manager to lead QC operations across our U.S. manufacturing facilities in Waltham, Norwood, and Billerica, MA.

You will develop and execute QC strategies aligned with FDA medical device requirements and ISO standards, partnering with Manufacturing, QA, Regulatory Affairs, and R&D to enable scalable growth. The ideal candidate will bring 5–10+ years of QC management experience, strong regulatory knowledge, and a track record in data-driven quality

Qualifications

• 5–10+ years of Quality Control management experience in FDA-regulated medical device/IVD settings.
• Strong knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA 21 CFR Part 820.
• Experience leading data-driven quality management, trend analyses, and executive-level reporting.
• Experience applying lifecycle risk management for IVD medical devices.
• Experience with multi-site manufacturing and cross-functional collaboration.

Responsibilities

• Lead QC functions across multiple U.S. manufacturing and distribution sites.
• Establish enterprise-wide QC strategies, policies, and performance metrics.
• Build and mentor QC teams while fostering accountability and continuous improvement.
• Ensure consistent QC practices, testing methodologies, and inspection standards.
• Drive quality improvements in product quality, yield, and manufacturing efficiency.
• Oversee data collection, monitoring, and reporting of quality metrics.

Skills

Quality Control management

Statistical analysis

Quality reporting

Process improvement

Leadership

Education

Bachelor’s degree or higher in Life Sciences or related field

Job description

Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Job Summary:

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. The Sr. Quality Control Manager will develop and execute comprehensive quality control strategies that support FDA medical device requirements, MDSAP, IVDR, ISO 13485, ISO 14971, and other applicable regulatory standards while enabling scalable growth across the organization.

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.

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.

Experience Requirements:

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

Physical Requirements and Working Conditions:

• 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.
• Occasional need to move about the office to access meetings or resources.

Why Work for Nova Biomedical

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

Work Location

Waltham, MA

Targeted Salary Range

$150,000-$170,000/yr

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

About the Company

At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

Explore what’s next with us at novabiomedical.com

EEO Statement

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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