Lead quality assurance for medical devices in Lelystad, covering the QMS, QA/QC, regulatory compliance, audits and product launches. Requires at least five years of QA experience with medical devices. Up to 40 hours per week; 40 hours is not required.
The role
At our client company in Lelystad, Flevoland, you will be responsible for quality management for medical devices. You will work with colleagues across departments in an international, multicultural team.
Responsibilities
- Implement, manage, maintain and improve the quality management system.
- Conduct management reviews and CAPA meetings.
- Act as the Person Responsible for Regulatory Compliance (PRRC), including in relation to the IVDR (EU) 2017/746 and MDR (EU) 2017/745.
- Hold overall responsibility for QA/QC activities, including final product release, inspections and training.
- Support product development projects across multiple sites and product launches. Ensure design and development activities are delivered and controlled, including design control, risk management, process validation, EU Declarations of Conformity (DoCs) and technical documentation.
- Identify and interpret new or revised regulatory requirements for medical devices.
- Coordinate audits and regulatory activities with relevant authorities, and check that devices conform to the manufacturer’s requirements before release.
What you bring
- At least five years of QA experience with medical devices.
- A recognised formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or quality management systems related to medical devices.
- Where custom-made devices are involved, at least two years of professional experience in a relevant manufacturing field.
- Experience working in a multicultural environment.
- Excellent spoken and written Dutch and English.
- A positive, solution-oriented and decisive approach, strong communication skills, resilience under pressure, the ability to keep an overview, creativity and attention to detail.
What is offered
- A challenging role in a modern, professional environment with a positive working atmosphere.
- A market-rate salary, good benefits and an attractive bonus opportunity.
- Opportunities for professional development and career progression, as well as the possibility of taking courses.
- The contract type is not specified. The role is for up to 40 hours per week; availability for a 40-hour week is not required. Specific working hours or shift patterns are not stated.