Senior Quality Director

Nova Biomedical Corporation • Waltham, MA

1d • Hybrid

About The Position

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. 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 or aicompanies.com About the role The Senior Director of Quality focuses on assuring company compliance to ISO/FDA QSR, IVDD, IVDR, ISO 13485, ISO 14971; Direct oversight of CAPA management, ISO/QSR employee training; metrics; validation, internal and external quality auditing processes; improvements. Primary responsibilities includes managing corporate level compliance activities along with day-to-day quality activities at the global Nova Biomedical manufacturing sites. Interact directly with management at other Nova subsidiaries on issues regarding QA systems and processes. If you’re passionate about quality assurance and want to be part of a team that is shaping the future of life sciences, we’d love to hear from you, apply today!

Requirements

• 12+ years of medical diagnostic or device experience managing a quality program
• 12+ years of quality team management
• BS Degree in the sciences or other technical discipline, or 10+ years of QA experience in the medical device or diagnostic industry
• Working knowledge of GMP is required
• Demonstrated ability to provide Root Cause Analysis tools and structured problem-solving methodologies to QMS issues
• Skilled at performing and leading internal and external audits

Nice To Haves

• Certified Quality Auditor and/or Certified Quality Manager through ASQ is a plus
• Strength in organizational skills
• Proven track record with process improvements
• Communication with various functional departments will be critical to achieving successful outcomes
• Strong communication and presentation skills
• Technical knowledge of Nova-type products is a plus
• Knowledge of LMS software

Responsibilities

• Provide leadership and support during external audits performed by regulatory bodies such as the FDA and TUV, Partners and Customers, as well as other auditing bodies
• Support conducting internal audits of Nova’s Quality System
• CAPA management of internal and external CAPAs for appropriate action, risk assessment, and effectivity
• Serves as Nova’s PLQC chair
• Management and execution of NIRs and other failure investigations
• Manage the Nova Shipping Hold processes and ensure timely interaction between functional groups
• Employee Quality Training design and delivery for company-wide compliance
• Oversight of approval process for NCMRs as part of the MRB process
• Supplier Quality Engineering support for review and approval of SQE CAPAs
• Provide quality leadership of company improvement projects
• Oversee validation activities and ensure effectiveness of process
• Ensure compliance with company procedures and processes
• Quality Planning – develop and execute plans related to product development as well as new project plans
• Oversee metrics and KPIs for evaluation and reporting at Senior Management Reviews
• Ensure timely response and feedback to Nova’s suppliers and ensure supplier-related issues are resolved in a manner that does not disrupt production processes
• Management of customer and partner qualifications, and ongoing compliance maintenance activities, such as SCARs, quality surveys, and quality agreements
• Provide quality support to Nova’s subsidiaries
• Management of documents of external origin (i.e. ISO Standards, Electrical Standards, etc.)

Benefits

• 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

What This Job Offers

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