Áreas Terapêuticas Woundcare
Job ID 21444
Descrição
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:
•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)
•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
