DET - QA Engineer
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
You will work closely with our team to perform quality assurance and control on the new product implementation manufacturing line. This is a Taiwan-based role that will engage with global teams and collaborate with stakeholders, internal/external subject matter experts, and industry authorities.
Main Responsibilities
Develop and implement comprehensive quality plans for new products, including inspection procedures, test plans, and control plans.
Monitor manufacturing processes to identify and address potential quality issues.
Execute quality inspections (FAI, in-process, outgoing) according to established inspection instructions and procedures.
Identify, document, segregate, evaluate, and dispose of nonconforming products.
Collaborate with cross-functional teams (engineering, manufacturing, supply chain) to define and maintain quality standards and metrics.
Conduct thorough investigations to determine root causes of failures and defects, and implement effective corrective actions to prevent recurrence.
Review and introduce suitable fixture solutions to enhance efficiency and accuracy in metrology, testing, and assembly processes.
Improve QC methods in testing/assembly fixtures to support smooth transition from NPI (New Product Implementation) to mass production.
Support technology transfer processes and develop WI/SOPs and related QC records for each NPI project.
Work closely with the engineering team to drive continuous improvement initiatives.
Implement corrective and preventive actions to prevent defects and improve process efficiency.
Qualifications
Higher diploma or bachelor’s degree in Science or Engineering.
Solid knowledge of statistics and analytical skills.
Strong understanding of quality management systems (e.g., ISO 9001) and relevant industry standards (e.g., IPC-A-610).
Proficiency in various testing equipment and tools.
Excellent problem-solving and analytical capabilities.
High attention to detail and commitment to quality.
Ability to work independently and as part of a team.
Proactive, detail-oriented, with strong communication skills.
Fluent in Mandarin and basic English.
