For our client, a prominent company in the medical devices industry based in Utrecht, we are seeking an experienced Quality Manager. This role is ideal for candidates who are passionate about ensuring the highest standards of quality in medical device manufacturing and compliance.
Role and Responsibilities:
- Oversee the Quality Management System (QMS) to ensure compliance with regulatory standards like ISO 13485 and FDA regulations.
- Manage and monitor all aspects of product quality, from development through manufacturing to post-market surveillance.
- Lead quality assurance teams, providing guidance and support in quality control and assurance processes.
- Conduct internal audits and coordinate external audits, ensuring compliance with industry regulations and continuous improvement of quality processes.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality standards are integrated throughout all stages of product development and production.
- Drive the implementation of corrective and preventive actions (CAPA) and oversee risk management activities.
- Foster a culture of quality within the organization, promoting awareness and training related to quality standards and regulations.
- Relevent bachelor’s or Master’s degree
- Minimum of 6 years of experience in quality management within the medical devices industry.
- Expert knowledge of medical device regulations (e.g., FDA, EU MDR) and quality standards (e.g., ISO 13485).
- Proven leadership skills with experience in managing quality assurance teams.
- Excellent communication and interpersonal skills, with the ability to work effectively across various departments.
This position offers the opportunity to play a pivotal role in maintaining and enhancing the quality of innovative medical devices, contributing significantly to patient safety and regulatory compliance in a highly dynamic and challenging industry.
Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at firstname.lastname@example.org.