Sr Quality Engineer (Product Design & Development)

ph3Sr Quality Engineer (Product Design Development) /h3pSHL 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. /ppbJob Overview /b /ppThe Sr Quality Engineer SHL Medical AG is responsible for the effectiveness and quality of product design and process developments and ensuring compliance with applicable medical device regulations and cGMP standards. Quality Engineer supports risk management activities, ensures that products are of high quality and directs product development decisions by promoting a Risk-Based approach. Quality Engineering tools, techniques, and methodologies apply to product development according to the company’s needs and applicable regulations. The job holder is directly involved in establishing and applying efficient design controls and risk management procedures and tools and actively cooperates with multiple departments. /ppbMain Responsibilities /b /pulliRepresent Quality Engineering in all Design Controls and Product Development related aspects /liliEnsure the efficiency of Design Controls (Quality by Design) in product development, process development and product maintenance activities /liliEnsure compliance with relevant medical device and cGMP standards and regulations /liliActively take part in and facilitate Product Development and Quality process improvement efforts /liliApply Quality Engineering principles and tools in a dynamic way to development projects /liliUtilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes /liliTeam member in digitalization programs related to QMS and product lifecycle management (PLM) /liliSupport Risk Management activities and directs product development decisions by promoting a Risk-Based approach /liliCollaborate with Subject Matter Experts to identify and trace critical-to-quality attributes (CTQs) through all product development phases and to establish the control strategy /liliSupport studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction. /liliPromote Advanced Product Quality Planning (APQP) and Design For Six Sigma (DFSS) /liliEnsure all functions adhere to SHL procedure’s requirements and standards during all development and manufacturing stages. /liliMinimum of 5 years’ experience hands‑on experience in product development from concept to launch within the Medical Device or Pharmaceutical industry /liliExpert knowledge of Design Controls and Product Development processes, particularly for medical devices and/or combination products. /liliKnowledge of ISO 13485, QSR 820, ISO 14971, IEC62366, IEC62304 /liliExperience in establishing processes, authoring procedures, and driving cross‑functional collaboration /liliExcellent communication and stakeholder management skills with a strong customer‑oriented approach. /liliConsensus‑building abilities to negotiate project deliverables, risks, and priorities. /liliTeam player and self‑starter capable of thriving in an international, cross-company environment. /liliSolution‑oriented mindset coupled with solid analytical and decision‑making skills. /liliWillingness to travel internationally (up to 5%). /liliFluent in written and spoken English. /li /ulpbPreferred Qualifications /b /pulliFluent in written and spoken German. /liliBachelor’s degree in engineering, life science or related scientific discipline /liliTraining and practical application of quality engineering methodologies (e.g. APQP, DMAIC, Lean, Design for Six Sigma) /liliWorking knowledge of statistical analysis and related software. /li /ulpbWe Offer /b /pulliChallenging assignments in a fast‑growing and innovative industry. /liliAn exciting opportunity in a fast‑growing international medical technology company. /liliA modern working environment with multicultural and dynamic teams. /liliA centrally located office in Zug, very close to the train station. /li /ulpInterested 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. /ppFor more information on SHL Medical, please visit: shl-medical.com/careers /ppbPlease note: We do not accept applications from recruitment agencies for this position. /b /ppWe like to keep things simple and efficient. Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter. /ph3Grounded in belonging, we strive for excellence /h3pWith almost 6,000 employees of 77+ different nationalities, 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. Together, we invest in our future to maintain our leadership position in self-injection solutions. /p /p #J-18808-Ljbffr