Quality Assurance Director
October 31
Description
• Job Title: Quality Assurance Director • Company Overview: Stirling Q&R is a highly regarded company in the medical devices sector, committed to delivering innovative and safe products to our clients. • Position Summary: As the Quality Assurance Director, you will be responsible for overseeing all quality assurance activities, implementing and maintaining quality management systems, and ensuring compliance with regulatory requirements. • Key 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. • Additional Information: • Location: Permanent position based in the UK, with opportunities for flexibility. • Strong leadership role with a focus on strategic impact.
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.
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