Quality Assurance Director

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Requirements:

• Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• A minimum of 8 years of experience in quality assurance within the medical device or pharmaceutical industry.
• Extensive knowledge of ISO 13485, FDA regulations, and EU MDR requirements.
• Proven leadership experience with a track record of successfully managing quality systems.
• Strong analytical skills and ability to drive data-informed decisions.
• Exceptional communication and interpersonal skills, with the ability to influence and work effectively with diverse teams.
• Experience in developing and leading training programs related to quality assurance.
• Ability to travel as required for audits and inspections, both domestically and internationally.

Responsibilities:

• Develop and implement the quality assurance strategy, policies, and procedures in alignment with company goals.
• Lead the Quality Assurance team in monitoring adherence to policies and regulatory compliance;
• Ensure that quality management systems meet industry standards.
• Oversee audits and inspections, ensuring readiness for both internal and external reviews.
• Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure quality is integrated throughout the product lifecycle.
• Provide training and support to staff on quality systems and regulatory requirements.
• Manage and investigate product complaints and adverse events, implementing corrective actions as necessary.
• Evaluate quality performance metrics and drive continuous improvement initiatives.
• Act as a key representative in front of regulatory agencies and maintain relationships with external partners.
• Stay updated on industry trends and regulatory changes; ensure the company adapts accordingly.