Sr. QC Manager

American Society for Quality; Waltham (MA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Hybrid and flexible work arrangements

Competitive 401k company match

Generous PTO and paid holidays

Tuition reimbursement

Job summary

Nova Biomedical seeks a Sr. Quality Control Manager to lead QC operations across multiple U.S. manufacturing facilities in Waltham, Norwood, and Billerica, MA, supporting biopharma and clinical systems. You will drive FDA medical device compliance, MDSAP, IVDR, and ISO 13485, while enabling scalable growth.

You will partner with Manufacturing, QA, Regulatory, R&D, and Operations to achieve quality objectives and commercialization goals in a collaborative, data-driven environment.

Qualifications

• Bachelor's degree or higher in a technical discipline.
• 5–10 years of Quality Control management in FDA-regulated medical devices/IVD.
• Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations.
• Experience developing product/process trend analyses and executive-quality reporting.
• Experience applying lifecycle risk management for IVD devices.
• Experience with root-cause investigations using structured methods.

Responsibilities

• Lead QC functions across multiple US sites.
• Establish enterprise-wide QC strategies and metrics.
• Mentor QC teams and foster accountability and continuous improvement.
• Ensure QC practices and inspection standards across facilities.
• Drive initiatives to improve quality, efficiency, and scalability.
• Collect, monitor, analyze, and report quality data.
• Lead root cause investigations and risk management activities.
• Collaborate with R&D, Manufacturing, and Supply Quality to drive improvements.

Skills

Project management

Leadership

Team development

Data analysis

Education

Bachelor's degree in Life Sciences/related field

Tools

IQ/OQ/PQ

ISO 13485

FDA 21 CFR Part 820 knowledge

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

TheSr. Quality Control Manageris 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

• Ability to travel between manufacturing facilities as needed.
• Ability to wear required Personal Protective Equipment (PPE).
• Ability to stand or sit for extended periods.
• Ability to work in front of a computer screen for prolonged periods.Ability to lift up to 35 pounds.

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.

Your next challenge starts right here. Find your new role 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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