For one of our clients in Gent, we are looking for a Quality Engineer Product.
Do you have a master degree in bio-environment and at least 3 years of experience?
This could be your new challenge!
Ensure that in-vitro diagnostic test kits are developed & maintained during the whole product life cycle to meet customer expectations & in compliance with current quality & regulatory requirements. Ensure customer satisfaction by providing appropriate solutions to customer complaints in a timely manner as part of an outstanding post-sales service.
- Review and approve technical documentation generated during the development process & improvement projects to ensure compliance towards applicable standards & regulations and procedures; participate to technical/design review meetings.
- Act as quality expert in project teams.
- Own and maintain the product risk management file from launch of the products.
- Write and/or approve changes & CAPA's.
- Handle and follow-up product complaints from end users, affiliates, distributors and partners and provide timely and appropriate solutions; assess impact of complaints on public health (member of Risk Assessment Committee).
- Manage, evaluate and improve Quality Management System processes (e.g. change control, CAPA, internal audits, complaint handling).
- Master degree in bio-environment (pharmacy, biology, biotechnology) or equivalent by experience.
- 3 years experience in pharmaceutical or diagnostic environment.
- 3 years experience in a Quality department
- Customer oriented / customer friendly
- Positive, proactive and flexible attitude
- Experience in Risk Management, Change control or CAPA is a plus
- Open minded, cooperative, takes initiative, able to communicate with impact
- Analytical, problem-solving capabilities
- Good written and oral communication skills
- Languages: Dutch & English - good knowledge written & spoken.
Existing right to work in Europe required ( please read job spec in full before applying ).