Deine Aufgaben

- Leading and moderation technical and monthly CAPA board meetings at site and multi-site levels
- Role as CAPA approver with responsibility for quality, completeness, and sustainability of CAPA content
- Coaching, mentoring, and developing CAPA teams, investigators, and approvers
- Conducting CAPA process and system training (on-site or virtually)
- Monitoring CAPA performance, timelines, and KPIs
- Subject Matter Expert (SME) for CAPA in quality management reviews, audits, inspections, and data analyses
- Moderation cross-functional root cause analysis sessions
- Collaborating with sites and the Global CAPA Center of Excellence to identify and address systemic or recurring issues
- Ensuring consistent CAPA implementation and timely completion

Deine Qualifikationen

- A completed university degree, preferably in engineering, natural sciences, or a related field
- Extensive experience in quality and a comprehensive understanding of the CAPA lifecycle (Issue Identification, Root Cause Analysis, Action Planning, Implementation, Effectiveness Check)
- Proficiency in RCA methods (e.g., 5 Whys, Ishikawa/Fishbone, structured problem-solving)
- Experience in moderation of cross-functional RCA workshops
- In-depth knowledge of relevant regulations and standards (e.g., FDA 21 CFR 210/211/820, ISO 9001 / ISO 13485)
- Experience in audit and inspection preparation as well as defending CAPAs
- Excellent communication- and cross-functional collaboration skills

Deine Vorteile

- Flexible working hours, remote work possible (up to 60%)
- 30 days of holidays per year
- Modern office and an inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100 % subsidized) or free parking space
- Company sport groups and an inhouse company gym
- Employee Assistance Program to support your health, mental and emotional well-being
- A comprehensive company pension scheme
- Company medical officer and vaccination offers
- Childcare through our ‘Buttje&Deern’ partner
- Company car, also for private use (for field staff only)
- Bike leasing

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