For a dynamic and globally operating Medical Devices company we’re looking for a
Quality Management System Engineer. In this role you will be responsible for maintaining standard operating procedures and the quality management system in operations. Ensure all quality control and quality assurance standards are met.
Tasks & Responsibilities
- Establish detailed guidelines/procedures on what needs to be checked and what the quality standards are.
- Update our Quality Management System (QMS) with incidents, fixes, and improvements.
- Audit our systems based on ISO 13485 and/or MDR requirements. Support external and internal audits to implement actions and clarify programs and processes.
- Support production readiness review efforts essential for QA.
- Revise and evaluate data to identify reportability and CAPA decisions; prepare reports on corrective actions of malfunctions.
- Submit events to be reported with regulatory authorities within the given timeframe as dictated by regulations.
- Prepare and execute procedures to conform to industry and corporate standards.
- Support the team to fulfill daily tasks, including but not limited to: receiving inspections, label inspections, stocking after sterilization, in-process inspection, final inspection, and release of products.
- Maintain competence in MDR requirements.
- Act as PRRC (team member) in case the PRRC is not available.
Requested Profile
- Previous work experience as a Quality Engineer or similar role
- Hands-on experience with Quality Management Systems (QMS) and testing methodologies
- In-depth understanding of technical documentation
- Great attention to detail and problem-solving abilities
- Strong sense of quality systems
- Ability to work independently and/or as part of a team
- Additional certification in Quality Assurance is a plus
- Internal auditor (ISO13485) certification is a plus
Practicalities:
- Location: Gelderland
- Direct contract
Interested or know someone?
Reach out to Aimee Brenner for more information by contacting +31 (0)20 20 44 502 or a.brenner@panda-int.com.