Senior Quality Director

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 include 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.

• 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; serve as Nova's PLQC chair
• Manage and execute NIRs and other failure investigations
• Manage the Nova Shipping Hold processes and ensure timely interaction between functional groups
• Design and deliver Employee Quality Training for company‑wide compliance
• Oversight of approval process for NCMRs as part of the MRB process
• Supply 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 and 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
• Manage customer and partner qualifications, and ongoing compliance maintenance activities such as SCARs, quality surveys, and quality agreements
• Provide quality support to Nova's subsidiaries
• Manage external documents (ISO Standards, Electrical Standards, etc.)

• Certifications are not required;
  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
• 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
• Technical knowledge of Nova‑type products is a plus
• Knowledge of LMS software
• 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

• The ability to work while standing or sitting for prolonged periods
• The ability to work on a laptop or desktop computer for prolonged periods
• The full list of physical requirements for this role is available upon request

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401(k) 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

Hybrid work schedule, onsite in our Waltham, MA office

$220,000 - $300,000 per year

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As 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.