About the Role

Are you a quality-driven engineering professional with a passion for precision, compliance, and making medical technology safer? We are looking for a Quality Engineer (m/w/d) to join our multidisciplinary team in Wangs, Switzerland, supporting validation, risk management, and quality assurance activities within a highly regulated medical device manufacturing environment.

This role sits at the intersection of engineering rigour and regulatory compliance — ideal for professionals with hands-on experience in process validation (IQ/OQ/PQ), risk management (FMEA, ISO 14971), and quality systems (ISO 13485, EU MDR).

We also welcome applications from professionals with backgrounds in Sterilization Validation and Quality & Regulatory Affairs.

What You Will Do

Quality & Compliance

• Support all quality development activities for commercial production

• Ensure compliance with internal procedures, FDA regulations, and applicable international standards (ISO 13485, EU MDR, ASTM)

• Serve as quality subject matter expert during regulatory and internal audits

Validation & Process Qualification

• Support validation and re-validation of test methods and manufacturing processes

• Develop, review, and approve protocols and reports for test method validation

• Implement IQ, OQ and PQ process qualification activities, including protocol and report review

Risk Management

• Cross-functionally collaborate with Manufacturing Engineering on FMEAs(design, production, user)

• Create, maintain, and approve risk management documents in line with ISO 14971 / 24971

Continuous Improvement & Problem Solving

• Lead and support CAPA processes: root cause analysis, problem-solving methodologies, and corrective/preventive action implementation

• Perform statistical analyses to determine process capability indicators using tools such as Minitab and DOE (Design of Experiments)

• Support the Manufacturing Engineering team across all quality-related tasks

What You Bring

Education

• Bachelor's degree in an engineering discipline (preferably Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Engineering)

Experience & Knowledge

• Experience in the medical device industry or a comparable regulated environment

• Practical knowledge of global MedTech standards: ISO 13485, ISO 14971/24971, EU MDR

• Hands-on experience with validation activities (IQ/OQ/PQ), statistical tools and CAPA processes

Skills

• Fluent in German and English — both written and spoken (mandatory)

• Strong analytical and problem-solving skills

• High level of accuracy and process-oriented working style

• Proficient in MS Office(especially Word)

• Knowledge of DOE and Minitab statistical software

• Collaborative mindset — comfortable working in multidisciplinary, international teams

Why Join Us

• Work in a state-of-the-art MedTech environment in Switzerland

• Be part of a cross-functional team where your quality expertise drives real patient impact

• Grow within a culture that values precision, accountability, and continuous improvement

• Engage with international standards and global regulatory frameworks on a daily basis