Quality Assurance Manager (CAPA and Production) 100%

About the job

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 successfully used worldwide in clinics and medical practices as well as by rescue organisations.

To strengthen our Quality Management team, we are looking for a motivated and committed individual to join us immediately or by arrangement as

Quality Assurance Manager (CAPA and Production) 100%

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

Your tasks

• Responsibility for the CAPA process according to ISO 13485, from initiation to effectiveness check and closure
• Triage and classification of incoming quality reports as well as risk-based decision-making on the initiation of CAPAs
• Moderation and execution of root cause analyses with cross-functional teams as well as management, follow-up and verification of corrective and preventive actions
• Quality technical support of production in case of quality problems and deviations as well as control of defective products
• Monitoring of incoming goods inspection including maintenance of test plans and sampling procedures as well as control of monitoring and measuring equipment
• Monitoring of CAPA and quality KPIs and reporting as input for 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 basic training with further education in quality management
• 3–5 years of professional experience in quality management in medical technology, with production-related reference
• Sound knowledge of ISO 13485, EU MDR and 21 CFR 820 as well as good knowledge of ISO 14971
• Proven 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 quality manager and auditor are an advantage
• Strong moderation and communication skills, constructive questioning and assertiveness without direct authority
• Structured, analytical and solution-oriented working style with high attention to detail
• Fluent German and English, spoken and written

Your prospects

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

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

Apply now at: www.schiller.ch/de/ueber-schiller/karriere, 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.