QA Compliance Manager

At Ypsomed, we shape the future of medical technology together - with the goal of sustainably improving the quality of life for people with chronic illnesses. We promote an open corporate culture where diversity is valued and new perspectives are welcome. Our employees take responsibility, work interdisciplinarily, and develop innovative solutions with real societal value.

As a QA Compliance Manager, you ensure within the team that the quality requirements defined by the headquarters are implemented globally, effectively monitored, and continuously improved. Your focus is on data-based trending, root cause analyses, NC/CAPA, change control, as well as enabling employees through training and coaching.

QA Compliance Manager | 80 - 100%

Ref No. 8256

Workplace: Solothurn | Hybrid

Your main tasks

• QA contact person for a defined product; support and coordination of standardised tasks in design and process transfer between Business Area/Design and Operations at designated production sites
• Leadership and management of NC/CAPA, changes, lessons learnt, risks and audits (product and process) and their KPIs within the area of responsibility - across sites and in coordination with stakeholders
• Support in training & coaching of employees on NC/CAPA, RCA, trending and risk-based decision making
• Participation in regulatory and customer audits as well as handling audit findings
• Proactive improvement of product and process performance through analysis, prioritisation of measures and sustainable effectiveness control

Your profile

• Completed technical or scientific degree (FH/Uni/HF) and at least 5 years of experience in QA Compliance/Quality Systems in the MedTech environment (ideally in the sterile environment for injection devices)
• Very good knowledge of ISO 13485 as well as practical experience with MDR and FDA QMSR / 21 CFR 820
• Proven experience in NC/CAPA, RCA methods and data-based trending with Excel and Power BI
• Lean / Lean Six Sigma (Green/Black Belt), statistics/SPC as well as training in internal audits according to ISO 13485 are advantageous
• High tool affinity (e.g. S4/HANA, quality tools such as TrackWise, Jira, Office, Excel)
• Very good German (C1) and good English skills (B2) in spoken and written form

Ypsomed – Self-treatment becomes a matter of course

Ypsomed is a leading developer and manufacturer of injection systems for the self-administration of liquid medicines. For over 40 years, the company has been a reliable partner to the pharmaceutical and biotech industries – with solutions precisely tailored to the needs of its customers. Ypsomed has a proven track record and offers the most comprehensive and innovative platform portfolio for pens, autoinjectors and on-body devices. The solutions impress with the highest implementation quality and can be seamlessly integrated into digital health offerings. They support simpler therapy and thus contribute to a better quality of life for people with chronic diseases.

Ypsomed is headquartered in Burgdorf (Switzerland) and operates a global network of production sites. Over 2,000 employees worldwide are committed daily to making self-treatment a matter of course.

Contact

Heiko Sieger
Workforce Acquisition & Engagement Partner

Your future workplace

Solothurn