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.
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