SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

MINIMUM REQUIREMENTS

• Minimum 3 years of experience in supplier quality management / preferable medical device or pharma
• Experience in interpreting and applying regulations and standards, auditing to these standards and processes good oral and written communications abilities
• Understanding of all engineering fields and internal processes to be audited
• Ability to be CAPA owner
• Industry know-how in medical devices and/or related fields
• Knowledge of production and business processes
• Experience in manufacturing industry (preferably medical devices or pharma) and in a quality organization
• Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel, SAP and MS Project etc.
• Overseas travel: Willingness and flexibility to travel overseas for approx. 30% of working time (customer meetings mainly in Asia and US, events, conferences, exhibitions etc.).
• Language: Fluent in English & German

PREFERRED QUALIFICATIONS

• Education: Bachelor’s degree in life science or Engineering
• Position requires a sound technical background (university degree, technical degree or equivalent of technical nature)
• Quality Manager training with Diploma examination (SAQ or equivalent) and Auditor training with Diploma examination (SAQ or equivalent) required

• Manages and monitors implementation and effectiveness of corrective actions related to NCR findings with a root cause on supplier.
• Assists suppliers in developing strategies for corrective action and preventive action
• Identifies risks to products and processes that trace to deficient quality systems, uncontrolled critical parameters, changing regulatory requirements, and changing technical requirements
• Collects and analyzes quality metrics from various quality systems and develops reports as needed
• Collaborates with Supplier Management and Purchasing department to track ongoing supplier quality performance and work with suppliers on quality issues
• Approve supplier selection through robust qualification processes
• Develop positive relationships and work closely with Supplier Management to manage and implement supplier changes, New Product Introductions, and transfer
• Support audit management during notified body audits as a frontroom / backroom member or SME
• Carrying out external system and process audits at suppliers as a lead auditor
• Developing, negotiating and concluding quality assurance agreements with supplier / subcontractors
• Following-up regulatory and corporate requirements
• Support Global Audit group, internal audit group for audits