Quality Engineer
My client is an international family-owned company with ambitious growth plans in both the pharmaceutical and medical device sectors. Focusing on skin-care related products, they have established themselves in Europe and will continue this trajectory into the US.
Looking to strengthen their quality team, they are searching for a Quality Engineer who will be responsible for the quality assurance of development projects, including supplier qualification and risk management. The role is based in the Kontich region of Belgium.
Responsibilities:
- Lead design and development activities to meet normative requirements.
- Perform supplier qualification processes, ensuring compliance with regulatory requirements and internal quality standards.
- Plan, conduct, and document supplier audits to assess adherence to ISO 13485, MDR and ISO 14971.
Qualifications:
- Master’s degree in Engineering, Life Sciences, Pharmacy, or a related field or a proven track record in the related field.
- Minimum of 5 years of experience in a Quality Engineering or Supplier Quality role within medical device industry (pharmaceutical experience is a plus).
- Strong knowledge of ISO 13485, MDR, ISO 14971 (any additional country regulation or knowledge on GMP is a plus).