Quality Assurance Manager (CAPA and Production) 100%

SCHILLER AG is an internationally leading medtech company in the field of heart and lung diagnostics, patient monitoring, defibrillation, emergency medicine, as well as software solutions for the medical industry. Our products, developed and manufactured in Switzerland, are used successfully worldwide in clinics and doctor's offices as well as by rescue organizations.

To strengthen our Quality Management team, we are looking for a motivated and committed personality as

Quality Assurance Manager (CAPA and Production) 100%

starting immediately or by arrangement.

Are you a quality-conscious person who enjoys working in a team? Do challenges motivate you and do you approach them independently and in a solution-oriented manner?

Your Tasks

• Responsibility for the CAPA process according to ISO 13485, from initiation to effectiveness review and closure
• Triage and classification of incoming quality reports as well as risk-based decision-making regarding the initiation of CAPAs
• Moderation and execution of root cause analyses with cross-functional teams as well as control, follow-up, and verification of corrective and preventive actions
• Quality technical support for production regarding quality problems and deviations, as well as control of non-conforming products
• Monitoring of incoming goods inspection including maintenance of inspection plans and sampling procedures as well as control of monitoring and measuring equipment
• Monitoring of CAPA and quality KPIs and reporting as input for the management review
• Training and coaching of employees in problem-solving methods and documentation standards
• Interface to Complaint Handling, Post-Market Surveillance, Risk Management (ISO 14971), Development, Purchasing, and Production
• Representation of the CAPA process and production-related QA processes during audits and inspections

Your Profile

• University degree (BSc/MSc) in engineering, natural sciences, or life sciences, alternatively technical vocational training with further education in quality management
• 3–5 years of professional experience in quality management in medical technology, with a production-related focus
• Sound knowledge of ISO 13485, EU MDR, and 21 CFR 820 as well as good knowledge of ISO 14971
• Demonstrable experience in leading root cause analyses and CAPA investigations
• Experience with Non-Conformities, incoming goods inspection, and monitoring of measuring equipment
• Technical understanding of manufacturing processes as well as drawings and specifications
• Experience with CAPA management systems/tools and ERP systems; certifications as a quality manager and auditor are an advantage
• Strong moderation and communication skills, constructive questioning, and assertiveness without direct line authority
• Structured, analytical, and solution-oriented way of working with high attention to detail
• Business fluent German and English in speaking and writing

Your Perspectives

Look forward to an exciting and varied challenge in a dynamic, international working environment. A professional, innovative, and supportive working atmosphere awaits you – embedded in the fascinating world of medical technology.

Our flexible working hours allow you to design your daily work individually. We actively support your professional development by offering you access to further training and specialist courses. In addition, all SCHILLER AG employees benefit from a comprehensive range of benefits.

Apply now at: , SCHILLER AG, Human Resources, Altgasse 68, 6341 Baar. We look forward to meeting you!

For this position, we only consider direct applications, thank you for your understanding.

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