{"id":4005590,"url":"https://alion.io/job/shl-medical-qe-program-manager","title":"QE Program Manager","company":{"id":1964724,"name":"SHL Medical","domain":"shl-medical.com","url":"https://alion.io/company/shl-medical","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Taoyuan, Taiwan"],"countries":["TW"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design of Experiments","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-11-10T06:55:08Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-10T06:55:08Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"About SHL Medical\nSHL 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.\nJob Overview\nThe QE Program Manager (Tech Transfers) drives cross-functional/cross-site to ensure product and process excellence in quality engineering. This role combines technical expertise in quality methodologies, data analytics, and regulatory compliance with quality leadership in tech transfer management. It not only focuses on improving efficiency, reducing risk, and ensuring products meet customer and regulatory standards throughout the product lifecycle but also ensures that the transferred process/system is feasibly implemented in receive site.\nMain Responsibilities\nLeadership & Tech Transfer ManagementLead/Involve in QE project’s tech transfer, managing resources and schedules\nProvide technical leadership and mentoring junior engineers or team members\n\nTech Transfer & Quality EngineeringReview and approve manufacturing system/process documents (system D&V documents, work/maintenance instructions, risk management documents, etc.) to ensure that system design is suitable and feasible for production need/operation and overall process risks are controlled at certain levels to fulfill external and internal stakeholders’ expectations.\nApply quality engineering knowledge and skills in area of:\n\nStatistical Process Control (SPC)\nDesign of Experiments (DoE)\nRisk Management\nEquipment/Process Development and Verification/Validation\nRoot Cause Analysis and CAPA\n\nCross-functional CollaborationWorking with cross-functional teams such as PD, Productions, QA, QC, Supply Chain, IT etc. and collaborate during tech transfer, which includes system qualification, process validation, and quality improvement initiatives, etc.\n\nStakeholder EngagementCommunicate with suppliers and internal stakeholders to resolve quality issue and align on expectations.\n\nRegulatory & Compliance FocusEnsure compliance with internal standards and external regulations (e.g., ISO 13485, FDA 21 CFR 820) and meet requirements of design control and risk management.\n\nMinimum Qualifications\nBachelor’s or Master’s in Engineering, Quality, Data Science or related field.\n5+ years in Quality Engineering or Product/Process Development in regulated industries\nKnowledge of manufacturing processes (e.g., molding, metal part, assembly, automation, etc.)\nSkilled in Six Sigma, Lean, DFSS, APQP, and statistical tools\nFamiliar with ISO 13485, FDA 21 CFR 820, ISO 14971\nStrong thinker with hands-on execution ability\nWilling to travel internationally (up to 30%)\nTechnical expertise in below area:SPC, DoE, FMEA, CAPA\nData analytics\nProcess D&V\nTech transfer\n\nLanguage skills\nMust have : Fluent in English\nNice to have : Mandarin","description_format":"text","description_chars":3351,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-11-10T06:55:08Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring 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