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.
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γJob Overviewγ
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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.
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γResponsibilitiesγ
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- 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 (βNPIβ) 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.
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γQualificationγ
- Higher diploma or Bachelorβs 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