Job Title: Senior Supplier Quality Engineer
At our company, we are seeking a highly skilled and experienced Senior Supplier Quality Engineer to join our team in Geneva.
Main Responsibilities:
1. Maintain and implement supplier management processes to ensure strong and effective relationships with key suppliers.
2. Participate in the selection, qualification, and periodic evaluation of suppliers according to established procedures.
3. Ensure timely processing and follow-up of supplier complaints and change notifications.
4. Organize and participate in change impact assessment meetings.
5. Plan, organize, and carry out supplier and distributor audits to ensure compliance with quality standards.
6. Handle quality events such as non-conformity, out-of-specification products, change control, and corrective actions in collaboration with other departments.
7. Lead problem-solving groups and support continuous quality improvement projects.
8. Foster internal communication by feeding back information from various departments within the Quality Department.
9. Serve as a quality referent on projects, reviewing new design specifications and providing input on component quality and manufacturing feasibility.
10. Investigate supplier material failures and develop corrective action plans if necessary.
11. Develop material acceptance criteria and activities.
Requirements:
1. Demonstrated mastery of quality standards ISO 9001 & 13485.
2. Knowledge of Medical Device Regulations (MDR).
3. Proficiency in quality tools such as 5P, 5M, 8D, and risk analysis methods.
4. Excellent English language skills, with good comprehension and writing skills (minimum level B2).
5. Basic training in Cryogenic Fluid Handling (CFC) or equivalent.
6. A minimum of 5 years of experience in quality roles within the pharmaceutical and/or medical device industry.
7. Ability to work autonomously, with a high level of rigor, and as part of a collaborative team environment.