To support our strategy we are strengthening is strengthening our quality & compliance team with a Supplier Quality Engineer position.
You carry the responsibility to build & manage a compliant supplier qualification program & to establish effective supplier relations to guarantee the product quality of goods & services delivered by supplier:
- You implement and maintain supplier related procedures compliant with all applicable regulations,
- You evaluate the suppliers’ ability to meet the quality requirements,
- You negotiate with suppliers on supplier quality agreements,
- You set up a supplier audit planning and you perform supplier audits
- You act as spokesperson during internal and external audits in relation to supplier qualification procedures and activities.
You participate in development and improvement projects to ensure that supplied goods/services are compliant with the quality & regulatory requirements:
- You approve quality requirements and related incoming quality control procedures following new product developments,
- You review and approve raw material related protocols & reports supporting root cause analyses or changes, corrective and preventive actions related to product quality,
- You maintain raw material related risk management files.
You support the QC department (troubleshooting, training, expertise, …) related to incoming raw materials.
Master in pharmacy, (bio)-engineering, (bio)-chemistry or biology
3 years experience in a GxP environment, preferentially in quality assurance in pharmaceutical, biotechnology or medical device industry
Knowledge & understanding of worldwide quality standards and guidelines, e.g. ISO13485, CFR Part 820
Knowledge & understanding of worldwide design control related regulatory standards & regulations
Good communication and negotiation skills
Project management experience
Good written and oral communication skills
Team player: open minded, cooperative, takes initiative
We welcome your application and the possibility to evaluate your curriculum!
Tel : 09 329 15 48