Quality Engineer
Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.
At Flen Health, we focus on people with topical inflammatory and infectious diseases. Our vision is to shape a world, where wounds and skin disorders do not stop patients from living the life they love by developing innovative technologies and distributing them across the globe.
At Flen Health, we expect you to show grit, take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working ecosystem, enthusiastic colleagues, and an attractive remuneration package.
We are looking for a Quality Engineer for an immediate start to strengthen our Quality team. This is a permanent full-time position located in our office in Kontich, Belgium.
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.
Your 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
•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
•Act as a back-up for the quality manager product life-cycle
•Collaborate with cross-functional teams to support new product development and ensure seamless quality integration
•Work closely with production and R&D teams to maintain our quality standards in the manufacturing process
•Drive continuous improvement initiatives to enhance quality systems, supplier performance, and compliance processes
•Support internal and external audits, including regulatory inspections and certifications
Your qualifications & experience:
•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)
•Proven experience conducting supplier audits and managing supplier qualification processes.
•Ability to analyze and interpret technical documents, regulatory guidelines, and quality standards
•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
What we offer:
•Excellent working conditions
•An innovative and inspiring work environment
•Independent project work & responsibilities within a professional team
•Career prospect
•Learning and development opportunities
•Competitive remuneration according to experience