Director Quality Assurance, Medical Device

We have been engaged for a Director of Quality Assurance position. In this role, you will oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance. The Director of Quality Assurance will ensure compliance with applicable regulations and standards and play a crucial role in ensuring safety, efficacy, and compliance.

Responsibilities:

• Oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, Health Canada, and European MDRs.
• Manage all aspects of the Quality Management System (QMS), including the Quality Manual and procedures/processes, such as document and data control, quality planning, training, vendor approval/monitoring, equipment maintenance and calibration, complaint handling and trending, product recalls/advisory notices, corrective and preventive action system, non-conforming materials, and incoming and final inspection.
• Manage design control activities for new and sustaining product development efforts, including risk analysis activities, such as design and process FMEA, design and process (IQ/OQ/PQ) validation/verification activities, and software validation.
• Oversee sterilization validation & biocompatibility compliance testing for single-use disposable and reusable accessories.
• Manage the clean room environment for single-use and reusable accessory processing, including certification and maintenance to international standards.
• Conduct internal and external audits of the Quality System.
• Represent the QMS internally (Authorized Management Representative) and to external customers.
• Report on the performance of the quality management system to senior management.

Requirements:

• Bachelor’s degree in a scientific, biomedical, or engineering discipline.
• 15 years of experience in Medical Device Quality Assurance, with a minimum of 5 years of hands-on management experience.
• Design Assurance experience.
• Experience with electro-mechanical medical devices.
• New product development, medical devices.
• Solid knowledge of applicable regulations, such as FDA 21 CFR Part 820 and ISO 13485, is required.
• Proven experience in building and leading technical teams.
• Solid knowledge of global regulatory requirements/standards.
• Direct experience in development and oversight of Quality Management Systems.
• Excellent interpersonal effectiveness and written/verbal listening/communication skills.
• Ability to evaluate and reorganize priorities quickly in a dynamic start-up environment.
• Excellent interpersonal skills and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.

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