Quality System Specialist

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.Job OverviewThe Quality System Specialist is responsible for ensuring compliance with all applicable regulations, including cGMP requirements. This role is part of the Global Quality Assurance function and supports the implementation and maintenance of the Site Quality System. This role provides active guidance to multiple departments to ensure adherence to SHL’s Quality and Regulatory procedures, as well as relevant agency policies and regulations. Additionally, the role is directly involved in developing and establishing site-level procedures.Main ResponsibilitiesBuild and maintain Site Quality Management SystemOversees implementation of quality assurance procedures, incl. change controlLead internal and supplier auditsSupport external auditsTrack KPIsLead and contribute to CAPA and NCsContribute to site QARA projectsProvide training on quality assurance procedures Supplier qualification including conducting of supplier auditsMinimum RequirementsMinimum 3 years’ experience in Quality Assurance of medical devicesPrevious experience in quality processes for medical devicesExperience in GMP and other Regulatory compliance requirementsAnalytical and problem-solving skillsOperates in a way that never compromises ethics and integrityAbility to understand and adapt to different cultures and market needsFluent in English both spoken and written.Preferred QualificationsBachelor’s degree in Life Science or EngineeringCertification in Purchasing or Supply Chain Management (e.g., CIPS, APICS).Certified internal auditor to ISO 13485Previous experience in quality management systems for medical device manufacturing organizationsCertified internal auditor to ISO 13485We OfferChallenging assignments in a fast-growing and innovative industry. A multicultural team and modern working environment with state-of-the-art facilities and technologies. A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth. Various opportunities for personal and professional development within a global organization. Flexible hours and hybrid working policy. Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.For more information on SHL Medical, please visit: shl-medical.com/careersPlease note: We do not accept applications from recruitment agencies for this position.