The Quality Assurance Specialist will ensure quality oversight of daily activities across product lines, implementing and maintaining QA processes to meet internal and external regulatory standards. This role is crucial in supporting Medion’s Quality System compliance.
Key Responsibilities
- Promote GMP culture across teams and ensure production practices meet product safety and efficacy standards.
- Manage non-product failure investigations, including root cause analysis, CAPA initiation, and documentation.
- Oversee change control processes, assess impacts, and maintain proper documentation.
- Train employees on Quality and GMP standards and support the QA team during audits and inspections.
- Maintain the Quality Management System, updating QA documents and ensuring regulatory compliance.
- Coordinate supplier qualification and certification with Purchasing, including risk-based supplier audits.
Who You Are
To succeed in this role, you should possess the following skills and qualifications:
- Skills: Effective communication, analytical thinking, problem-solving, and teamwork.
- Knowledge: Familiarity with ISO 13485, EU Regulation IVR 2017/746, and CFR Title 21, part 820.
- Education: Background in Life Sciences, Engineering, or related field, with a focus on quality management preferred.
Joining Grifols means the opportunity to work in an internationally oriented environment that promotes equal opportunities.
It offers you the chance to grow professionally, access continuous training, and be part of a team of professionals where each individual contribution truly matters. Our commitment is to foster a workplace that supports professional growth in a positive work environment.
The human capital at Grifols is essential to both the advancement of our activities and the expansion of our company.
If you’re interested in growing with us and your profile aligns with this opportunity, please send us your CV.
Job Types: 100%, Permanent
Pay: CHF90’000.00 - CHF130’000.00 per year
Work Location: In person
