Senior Quality Manager – Medical Device

My client is seeking a highly experienced Senior Quality Manager to join their team and lead the maintenance and continuous improvement of our Quality Management System (QMS) in compliance with all applicable regulations and standards for medical devices. The successful candidate will be instrumental in ensuring that our products meet the highest quality standards and regulatory requirements.

Responsibilities:

• Lead and manage Quality Engineers, Specialists, and Inspectors by providing direction, mentorship, and growth opportunities.
• Reporting on the performance of the quality management and proposing recommendations to improve the system to Senior Management.
• Vendor approval and monitoring.
• Manage the complaint handling system, including investigation, root cause analysis, and corrective actions. Monitor and analyze trends to identify areas for improvement.
• Develop and implement quality plans that align with company objectives, including risk management, validation activities, and product release criteria.
• Support, as needed, regulatory assurance, engineering, and Senior Management with regulatory filings, creation of technical files, vigilance/incident reports, internal and external audits, and sign-off for relevant documents.
• Corrective and preventive action system (CAPA), internal quality audits, non-conforming materials, and incoming and final inspection.
• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support manufacturing engineering in creating DMR, DHR, routers, bills of material, and specifications for in-house and external manufacturing.
• Conduct Internal Audits of the Quality System.
• Prepare for and participate in audits by external organizations, such as FDA, Notified Bodies, etc.

• 10-15 years of experience in medical device quality assurance is required.
• A minimum of 5 years of hands-on management experience is required.
• Bachelor’s degree in scientific, biomedical, or engineering discipline is required.
• Extensive experience in quality management within the medical device industry.Solid understanding of applicable regulations, including FDA 21 CFR Part 820, ISO 13485, Health Canada MDD’s, and European MDR’s.
• Experience in directly supporting manufacturing.
• Strong leadership and project management skills.
• Strong oral, written, and interpersonal skills required for interaction within the organization and external customers.
• Hands-on and results-oriented, with the ability to multitask.

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