Hiring: Senior Quality Director Company: Nova Biomedical Location: Waltham, MA Job Posted Time: 2026-09-03 10:18:46 Employment Type: Hybrid Target Skills & Keywords : R About the job Experience: •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. Required Skills: •Nova Biomedical is seeking a Senior Quality Director •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. Qualifications: •Bachelor’s degree in the sciences or another technical discipline, or 10+ years of quality assurance experience in the medical device or diagnostic industry. •Solid functional 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. •Demonstrated capacity to communicate effectively with various functional departments to achieve successful outcomes. •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. •Comfort with working at a computer for extended periods. Compensation: •$220,000 - $300,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!