Ensure risk of non-compliance and related business risks are mitigated
Provide quality / technical leadership through mentoring/coaching
Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards
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Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
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Quality Systems & Process Control: Monitor process capability (Cp/Cpk), implement PFMEA, Control Plans, SPC, MSA, and adhere to ISO/QMS standards.
Cross-Functional & Customer Advisory: Present technical failure analysis reports directly to clients and Customer Quality Engineering teams during critical escalations. Collaborate with Production, Engineering, Tooling, and SQE teams.
Education: Diploma or Bachelor's Degree in Engineering, Quality, Manufacturing, Polymer/Plastic Technology, or a related field.
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Defect & Deficiencies Management: Identifying, logging, and tracking Non-Conformance Reports (NCRs) and conducting root cause analysis (RCA) to prevent rework.
MEP Coordination: Ensuring the architectural and structural envelope seamlessly integrates with critical MEP (Mechanical, Electrical, and Plumbing) services.
QAQC Manager- Civil & Structural (Data Centre Construction) - Johor Bahru (Construction Multinational)
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