Senior Quality Director

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:

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:

• Ability…