QE - PQE Lead
Taoyuan, Taiwan
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
PQE Lead requires deep expertise in primary manufacturing processes (molding and/or assembly), and the ability to establish and maintain validated processes across global sites.
Main Responsibilities
- Lead cross functional team for moulding and/or assembly processes to ensure compliance with internal standards, customer product specifications, and customer quality agreement.
- Collaborate with cross-functional teams (Process Development, Operations, Supply Chain, QA, QC) during new product/process introductions (NPI) to ensure robust process controls, end-to-end process validation, and smooth transitions to mass production.
- Support global manufacturing sites by standardizing best practices, sharing lessons learned, and providing technical guidance and troubleshooting expertise.
- Drive continuous improvement initiatives focusing on upskilling production workforce, fool prove controls as process risk mitigation and systematically addressing the root cause of mass production nonconformities and deviations during process qualification & validation.
- Collaborate with cross-functional teams (R&D, Operations, Supply Chain) during new product introductions (NPI) to ensure robust process controls and smooth transitions to mass production.
- Own and lead NCMR investigations and drive corresponding CAPA.
- Provide mentoring and technical leadership to junior engineers and quality team members.
Qualifications
- Expertise in a process quality engineering role
- Hands-on expertise in molding and/or assembly processes.
- Experience leading CAPA across multi-site operations.
- Excellent communication, technical leadership skills, and influence other functions with the goal of meeting customers’ product specifications.
Language
- Must have: Fluent in English for coordinating and reporting across teams
- Nice to have: Mandarin
We Offer :
- Challenging 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.
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/careers
Please note: We do not accept applications from recruitment agencies for this position.
