SHL Medical Hiring! Full Time QE Program Manager in 桃園市, 台灣 - Ricebowl

About SHL Medical

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 Overview

The 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.

Main Responsibilities

• Leadership & Tech Transfer Management
  • Lead/Involve in QE project’s tech transfer, managing resources and schedules
  • Provide technical leadership and mentoring junior engineers or team members
• Tech Transfer & Quality Engineering
  • Review 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.
  • Apply quality engineering knowledge and skills in area of:

• • Statistical Process Control (SPC)
  • Design of Experiments (DoE)
  • Risk Management
  • Equipment/Process Development and Verification/Validation
  • Root Cause Analysis and CAPA
• Cross-functional Collaboration
  • Working 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.
• Stakeholder Engagement
  • Communicate with suppliers and internal stakeholders to resolve quality issue and align on expectations.
• Regulatory & Compliance Focus
  • Ensure compliance with internal standards and external regulations (e.g., ISO 13485, FDA 21 CFR 820) and meet requirements of design control and risk management.

Minimum Qualifications

• Bachelor’s or Master’s in Engineering, Quality, Data Science or related field.
• 5+ years in Quality Engineering or Product/Process Development in regulated industries
• Knowledge of manufacturing processes (e.g., molding, metal part, assembly, automation, etc.)
• Skilled in Six Sigma, Lean, DFSS, APQP, and statistical tools
• Familiar with ISO 13485, FDA 21 CFR 820, ISO 14971
• Strong thinker with hands-on execution ability
• Willing to travel internationally (up to 30%)
• Technical expertise in below area:
  • SPC, DoE, FMEA, CAPA
  • Data analytics
  • Process D&V
  • Tech transfer

Language skills

• Must have : Fluent in English
• Nice to have : Mandarin