Ph3Job Overview /h3 pSHL 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. /p pThe Process Quality Engineer (PQE) is responsible for supporting new process development, injection moulding and assembly process development and product transfer by applying quality engineering skills in compliance with medical devices industry standards and regulations. The Sr PQE will handle projects and tasks, from product/process inception through product launch, scale‑up, deployment, and retrofit projects. /p pThe Process QE will also be key in ensuring that Customer Requirement, Quality Compliance requirements are constantly met including, but not limited to FDA Quality System Regulation 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, and applicable technical standards. /p h3Main Responsibilities /h3 ul liRepresents Quality Engineering and quality requirements on process and equipment design development, with a focus on, but not limited to, plastic component manufacturing / injection moulding process development, throughout the Product Lifecycle. /li liLeads control planning activities, practices Quality tools (i.e. TQM, QFD, Risk Assessments) to evaluate control action for process/equipment /li liLeads and facilitates best practices of Process‑FMEA, and other risk assessment tools to ensure the identification of critical process parameters, and that risk controls are identified, implemented and effective /li liPromotes the risk‑based and scientific approach to process and equipment design development, /li liPromotes the use of applied statistics in engineering studies and investigations, /li liConsolidates and reviews lessons learned and historical data for robust and risk‑free process /li liSupports the creation of robust, manufacturable Design Outputs and their translation into DMRs through an efficient design transfer process (Design for Manufacturing) /li liSupports and reviews process/equipment verifications activity (engineering runs, protocols and reports) /li liSupports the validation activities (engineering studies, DOEs, IQ/OQ/PQ) planning and execution /li liSupport selected qualification activities (e.g., advanced inspection performance check, sterilization validation, etc.) with external suppliers. /li liEnsure proper design and development activities and documentation as per ISO 13485/FDA QSR Quality System. /li liStrong understanding of injection moulding processes /li liHands on experience in Advance Product Quality Planning and Control Plan (APQP), and practical in-depth know‑how and experience of quality techniques; Six Sigma methods, Quality Function Deployment (QFD), Process Capability analysis, ANOVA, DMAIC, DoE, FMEA, control chart etc. /li liExperience in Measurement System Analysis (MSA) and Gauge Repeatability and Reproducibility (GRR) /li liExperience in GAMP5 V model and verification/validation activities such as FAT/SAT and IQ/OQ/PQ /li liGreat understanding and demonstrated experience in applied statistics /li liStrong analytical, and problem‑solving skills /li liStrong writing and verbal communication skills (technical writing, risk documentation, stakeholder alignment, coaching and influence). /li liFluent in written and spoken English. /li liMinimum 5 years of work experience in New Process Development, Process and Equipment/System development and qualification function in medical devices and/or other regulated industry (e.g., aviation, automotive) /li liMaster’s degree in engineering or life science field (or equivalent experience). /li liStrong writing and verbal communication skills (technical writing, risk documentation, stakeholder alignment, coaching and influence). /li liFluent in written and spoken English. /li /ul h3Qualifications /h3 ul liMinimum 5 years of work experience in New Process Development, Process and Equipment/System development and qualification function in medical devices and/or other regulated industry (e.g., aviation, automotive) /li liMaster’s degree in engineering or life science field (or equivalent experience). /li liStrong understanding of injection moulding processes /li liHands on experience in Advance Product Quality Planning and Control Plan (APQP), and practical in‑depth know‑how and experience of quality techniques; Six Sigma methods, Quality Function Deployment (QFD), Process Capability analysis, ANOVA, DMAIC, DoE, FMEA, control chart, etc. /li liExperience in Measurement System Analysis (MSA) and Gauge Repeatability and Reproducibility (GRR) /li liExperience in GAMP5 V model and verification/validation activities such as FAT/SAT and IQ/OQ/PQ /li liGreat understanding and demonstrated experience in applied statistics /li liStrong analytical, and problem‑solving skills /li liStrong writing and verbal communication skills (technical writing, risk documentation, stakeholder alignment, coaching and influence). /li liFluent in written and spoken English. /li /ul h3Preferred Qualifications /h3 ul liPrior involvement in technology transfer projects across sites or regions /li liExperience working with external suppliers, on technical reviews and quality assurance /li liExperience with mechanical design (CAD, tolerance analysis) /li liSigma certification (Green Belt minimum; Black Belt preferred) or equivalent demonstrated competence /li liFluent in written and spoken English. /li /ul h3We Offer /h3 ul liChallenging assignments in a fast‑growing and innovative industry. /li liAn exciting opportunity in a fast‑growing international medical technology company. /li liA modern working environment with multicultural and dynamic teams. /li liA centrally located office in Zug, very close to the train station. /li /ul pPlease note: We do not accept applications from recruitment agencies for this position. /p /p #J-18808-Ljbffr