DET QARA - QA/QC Engineer

SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.

【Job Overview】

You will be working closely with our team to conduct quality assurance and control in our new product implementation manufacturing line. This is a Taiwan-based role that will work across the global organization and collaborate with stakeholders, internal/external Subject Matter Experts and Industry Authorities.

【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 inspection (FAI, in-process, outgoing) following the inspection instruction/procedure.
• Identification, documentation, segregation, evaluation and disposition of nonconforming product.
• Collaborate with cross-functional teams (engineering, manufacturing, and supply chain) to establish quality standards and metrics.
• Conduct thorough investigations to determine the root causes of quality failures and defects. Implement effective corrective actions to prevent recurrence.
• Review and implement suitable fixture solutions to enhance QC efficiency and accuracy in metrology/testing/assembly
• Improve current QC methods in testing/assembly fixtures to support new product implementation (“NPI”) manufacturing to mass production equivalent
• Support tech transfer process and creation of WI/SOPs and corresponding QC records per NPI
• Collaborate closely with team member and keep making continuous improvement
• Implement corrective and preventive actions to prevent defects and improve process efficiency.

【Qualification】

• Higher diploma or Bachelor’s degree in Science or Engineering
• Statistics knowledge and analytical skills
• Strong understanding of quality management systems (e.g., ISO 9001) and industry standards (e.g., IPC-A-610).
• Proficiency in using various testing equipment and tools.
• Excellent problem-solving and analytical skills.
• Strong attention to detail and a commitment to quality.
• Ability to work independently and as part of a team.
• Proactive, detail oriented, effective communication
• Fluent Mandarin and basic English