We are looking for a Quality Engineer for our client specialized in Wound Care.
In this role, you will be responsible for the quality assurance of development projects including supplier qualification and risk management.
Besides you are responsible to audit production suppliers, analyse data to continuously maintain the risk management files and to act as a back-up for the quality manager product lifecycle. You will play a pivotal role in ensuring compliance with industry regulations and maintaining the highest quality standards in our medical device production processes.
Interested? Send us your cv at benelux@talent.inizioengage.com or apply via Linkedin.
Job description:
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
Act as subject matter expert and process owner for product risk management
Evaluate and manage design change, ensuring that the product safety and performance is in compliance with quality and regulatory standards and regulations
Establish, negotiate, and maintain quality agreements with suppliers and contract manufacturers involved in the design and development
Collaborate with cross-functional teams to support new product development and ensure seamless quality integration
Drive continuous improvement initiatives to enhance quality systems, supplier performance, and compliance processes
Your profile:
Masters 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)
Strong communication and negotiation skills, with the ability to engage with internal teams and external partners
Problem-solving mindset with a proactive approach to quality improvement
Fluency in English is required; proficiency in Dutch and/or French is a plus
Living nearby the office (Central in Flanders) or willing to commute
Job offer:
Contract via client immediately
An innovative and inspiring work environment
Independent project work & responsibilities within a professional team
Learning and development opportunities
Competitive remuneration according to experience