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TECAN CDMO SOLUTIONS PN SDN. BHD. is seeking a Senior Supplier Quality Engineer to drive supplier quality excellence through proactive audits, SCAR management, and CAPA implementation.
You will mentor junior SQEs and collaborate with IQC, Procurement, and Engineering across global and local suppliers from NPI through mass production. Responsibilities include leading supplier assessments, ensuring regulatory compliance (ISO 9001, IATF 16949, ISO 13485 as applicable), and driving risk mitigation
Objective: To drive supplier quality excellence by ensuring all purchased products conform to specifications, industry standards, and regulatory requirements. This role leads to proactive supplier development, reduces non-conformance, and implements robust corrective actions to minimize the nonconformance.
Scope: This position covers direct material suppliers (mechanical, electrical, electro-mechanical components and other parts) across global entities and local suppliers within T-CDMP, from New Product Introduction (NPI) through mass production. The Senior Supplier Quality Engineer leads high-impact supplier audits, and mentors junior SQEs.
Drive supplier quality improvement through SCAR reports, focusing on effective containment, thorough root cause analysis, and the implementation of corrective and preventive actions in timely manner.
Develop, review and amend of Forms, Working Instructions and Procedures when need arises.
Conduct supplier assessment and audit together with Procurement and engineering department based on analyzing data trend.
Collaborate with IQC team on inspection criteria and defect trends.
Support disposition of non-conforming materials issued by IQC, In-Process and Outgoing inspection.
Identify high-risk suppliers and components further course of action. This shall be a collaboration with procurement and engineering.
Implement risk mitigation plans (e.g., increased inspection etc) when needed.
Participate in FMEA and control plan reviews.
Work with customers whenever is needed pertaining to any consign/non consign parts.
Maintain records of SCARs, audits, and supplier performance.
Ensure compliance with standards and regulations (e.g., ISO 9001, IATF 16949, ISO 13485, 21CFR 820 other regulations if applicable).
I work with Engineering, Procurement, Production, and engineering teams.
Be apart of “Sample Test Report” Reviewer and approver based on concession.
Support new product introduction (NPI) and supplier qualification.
Participate in CAPA (Corrective Action and Preventive Action) and quality review meetings.
Presenting Reports to management when necessary.
To conduct internal Audit within T-CDMP whenever required.
Perform any other duties as requested by superior from time to time.
Basic Education
Bachelor’s degree or Masters.
Experience
3 to 5 years of relevant working experience in Supplier Quality Engineering field for Seniors.
Fresh Graduate are accepted with training.
Language Skills
Ability to Speak/Write/Read English/Malay.
Technical Knowledge and Skills
Quality Management Standards, interpretation of Technical Drawings and Product Data Sheets, 7QC Tools, Problem solving method, DMAIC (optional), Lean manufacturing and other quality Tools.
Interpersonal Skills/ Competencies (Core &Leadership)
Highly motivated and self-discipline.
Interpersonal & Communicator still.
Ability to work independently with minimum supervision.
Able to solve complex problem using appropriate Quality tools.
About Tecan
Tecan is a global leader in laboratory automation and life sciences, helping customers accelerate healthcare innovation from research to the clinic. With more than 3,300 employees across Europe, North America, and Asia, Tecan offers meaningful careers where innovation, collaboration, and continuous learning drive positive impact on millions of lives worldwide.
About Tecan
Tecan is a global leader in laboratory automation and life sciences, helping customers accelerate healthcare innovation from research to the clinic. With more than 3,300 employees across Europe, North America, and Asia, Tecan offers meaningful careers where innovation, collaboration, and continuous learning drive positive impact on millions of lives worldwide.