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. We are looking for an experienced and strategic Quality Assurance Director to lead our quality assurance operations, ensuring compliance and excellence across all products.

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. You will play a critical role in shaping the quality strategy of the company and leading a team towards achieving the highest standards of product quality.

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.

Qualifications and Skills:

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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