We are seeking an experienced Quality Engineer to lead the implementation of a Quality Management System (QMS) and obtain ISO 13485 certification for our client. This role is critical to ensuring compliance with medical device regulations and maintaining the highest standards of quality.
Location: Flemish Region, Belgium
Type: Full-time (On-site preferred)
Length: 6-12 months contract
Key Responsibilities
* Drive the implementation and maintenance of the QMS in accordance with ISO 13485 requirements.
* Lead the certification process for ISO 13485.
* Collaborate with cross-functional teams to ensure compliance with regulatory standards.
Requirements
* Experience: Minimum 5 years in the medical device industry.
* Education: Engineering background (Bachelor's degree or equivalent).
* Strong knowledge of quality systems and regulatory requirements for medical devices.
* Excellent problem-solving and communication skills.
* Ability to work independently and manage multiple priorities.