Senior Quality Director

novabio; Waltham (MA); Hybrid; USD 220,000 - 300,000; Full time

Benefits offered by this job

Hybrid work arrangements

Competitive 401k match

Bonus program

Tuition reimbursement

Generous PTO and holidays

Job summary

Nova Biomedical in Waltham, MA, is seeking a Senior Quality Director to lead global quality and regulatory compliance across manufacturing sites, ensuring ISO/FDA QSR, IVDD/IVDR, ISO 13485, and ISO 14971 alignment.

You will oversee CAPA, audits, training, supplier quality, MRB, NIRs, and quality metrics, collaborating with R&D, Manufacturing, and Engineering to drive process improvements. Hybrid work in MA with a salary range of $220k–$300k.

Qualifications

• Bachelor’s degree in the sciences or a technical discipline, or 10+ years of quality assurance experience in medical devices.
• 12+ years of medical diagnostic or medical device experience managing a quality program.
• 12+ years of quality team management experience.

Responsibilities

• Provide leadership during external audits by regulatory bodies (FDA, ISO auditors) and partners.
• Lead internal audits of the Quality System and manage CAPA processes.
• Oversee NCMRs, MRB, and supplier quality activities to ensure compliance and timely resolutions.
• Develop and deliver employee quality training to support company-wide compliance.
• Oversee validation activities and ensure process effectiveness.

Skills

GMP knowledge

Root cause analysis

Audits

Quality management

Cross-functional communication

Training

LMS software

Education

Bachelor’s degree or equivalent

Tools

LMS software

Job description

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

Job Summary:

Nova Biomedical is seeking a Senior Quality Director, to lead corporate-level quality and compliance activities across Nova Biomedical’s global manufacturing sites. This role is responsible for assuring company compliance with applicable regulatory and quality standards, including ISO/FDA QSR, IVDD, IVDR, ISO 13485, and ISO 14971. The Sr. Director, Quality will provide direct oversight of CAPA management, ISO/QSR employee training, quality metrics, validation, internal and external audit processes, and quality system improvements. This position will also manage day-to-day quality activities across global Nova Biomedical manufacturing sites and interact directly with management at Nova subsidiaries on quality assurance systems and process-related matters.

Responsibilities:

• Provide leadership and support during external audits performed by regulatory bodies, including FDA and TUV, as well as audits conducted by partners, customers, and other auditing bodies.
• Support and conduct internal audits of Nova Biomedical’s Quality System.
• Manage internal and external CAPAs, including appropriate action planning, risk assessment, and effectiveness verification.
• Serve as Nova Biomedical’s PLQC Chair.
• Manage and execute NIRs and other failure investigations.
• Manage Nova Biomedical’s shipping hold processes and ensure timely interaction between functional groups.
• Design and deliver employee quality training to support company-wide compliance.
• Oversee the approval process for NCMRs as part of the MRB process.
• Provide Supplier Quality Engineering support for the review and approval of SQE CAPAs.
• Provide quality leadership for company improvement projects.
• Oversee validation activities and ensure process effectiveness.
• Ensure compliance with company procedures, processes, and applicable quality system requirements.
• Develop and execute quality plans related to product development and new project initiatives.
• Oversee quality metrics and KPIs for evaluation and reporting during Senior Management Reviews.
• Ensure timely response and feedback to Nova Biomedical suppliers and ensure supplier-related issues are resolved without disrupting production processes.
• Manage customer and partner qualifications and ongoing compliance maintenance activities, including SCARs, quality surveys, and quality agreements.
• Provide quality support to Nova Biomedical subsidiaries.
• Manage documents of external origin, including ISO standards, electrical standards, and related external regulatory or quality documents.
• Interact cross-functionally with departments impacted by Nova Biomedical’s Quality System, including R&D, Manufacturing, Engineering, Supplier Quality Engineering, Incoming Inspection, Purchasing, and Technical Support.

Experience Requirements:

• Bachelor’s degree in the sciences or another technical discipline, or 10+ years of quality assurance experience in the medical device or diagnostic industry.
• 12+ years of medical diagnostic or medical device experience managing a quality program.
• 12+ years of quality team management experience.
• Working knowledge of GMP is required.
• Demonstrated ability to apply root cause analysis tools and structured problem-solving methodologies to quality management system issues.
• Skilled in performing and leading internal and external audits.
• Proven track record driving process improvements.
• Strong organizational, communication, and presentation skills.
• Ability to communicate effectively with various functional departments to achieve successful outcomes.
• Knowledge of LMS software.
• Technical knowledge of Nova Biomedical-type products is a plus.
• Certified Quality Auditor and/or Certified Quality Manager certification through ASQ is a plus, but not required.

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: Hybrid work schedule, onsite in our Waltham, MA office

Targeted Salary Range: $220,000 - $300,000/year

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

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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