Senior Quality Director

Job Summary

Nova Biomedical is seeking a Senior Quality Director to lead corporate-level quality and compliance activities across the company's global manufacturing sites. This role ensures compliance with regulatory standards and supports critical workflows.

Responsibilities

• Support and conduct internal audits of Nova Biomedical’s Quality System.
• Manage internal and external CAPAs, including action planning, risk assessment, and effectiveness verification.
• Serve as Nova Biomedical’s PLQC Chair. Manage and execute NIRs and other failure investigations.
• 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

• Ability to work at a computer for extended periods.
• Ability to lift and carry up to [25–50] pounds as required.
• Ability to communicate effectively via phone, video, and written communication.
• Ability to occasionally 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

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.

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.