Associate Director of Quality – Medical Devices – The Netherlands

Title: Associate Director of Quality

Reporting To: COO

Industry: Life Sciences – Pharmaceutical

Salary: Negotiable – depends on experience

Location: Leiden

At Darwin Recruitment, we are proud to be partnered with a leading Medical Device company. They are A leading and innovative player in the medical device industry who are seeking an exceptional Associate Director of Quality to join their expanding team in The Netherlands. This company is renowned for its commitment to advancing healthcare technology and delivering products that meet the highest standards of quality and safety. As they continue to grow, they are looking for a skilled professional to take on a key leadership role within their Quality Assurance department.

Position Overview:

In this high-impact role, you will lead the Quality Assurance (QA) team and oversee the quality management system (QMS), ensuring compliance with global regulatory standards. Your efforts will directly contribute to the company’s mission of delivering safe and effective medical devices to the market. This is a unique opportunity for an experienced quality professional to step into a leadership position and drive continuous improvement in a fast-paced and dynamic environment.

Your Responsibilities:

Your responsibilities include but not limited to the following:

• Leadership & Management:

• Provide leadership and mentorship to the QA team, fostering a culture of excellence and accountability.
• Align quality initiatives with company objectives, ensuring adherence to regulatory standards.

• Quality Management System (QMS):

• Manage the development, implementation, and maintenance of the QMS, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
• Oversee quality documentation, including SOPs, CAPAs, change controls, and risk assessments, ensuring accuracy and completeness.

• Regulatory Compliance:

• Ensure all products and processes meet applicable regulatory requirements.
• Lead internal and external audits, including FDA, ISO, and customer audits, and manage the timely completion of audit responses and corrective actions.

• Product Quality:

• Implement and monitor quality control processes across the product lifecycle, from design and development to manufacturing and post-market surveillance.
• Collaborate with cross-functional teams to resolve quality issues and implement effective corrective actions.

• Continuous Improvement:

• Identify opportunities for process improvements to enhance product quality and operational efficiency.
• Stay abreast of industry trends, regulatory updates, and best practices to ensure the company remains competitive in quality management.

Your Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• 8-10 years of experience in quality assurance within the medical device industry.
• Deep understanding of ISO 13485, FDA 21 CFR Part 820, and related regulations.
• Proven leadership and team management skills.
• Strong problem-solving abilities, with excellent communication and project management skills.
• Ability to thrive in a fast-paced, cross-functional environment.
• Fluency in English; proficiency in Dutch is an advantage.

Please apply or email james.allen@darwinrecruitment.com for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

James Allen