• Developing and implementing quality assurance strategies to drive continuous improvement and enhance customer satisfaction.
• Managing the quality assurance team and ensuring that all processes, from raw materials to final product, adhere to internal guidelines and external regulatory requirements.
• Conducting audits and evaluations to assess compliance with quality standards and regulatory requirements.
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Support review and closure of corrective actions required by customers in a timely manner. Challenge submitted corrective actions of suppliers to assure their effectiveness and appropriateness; validate root cause analysis against reported failure analysis.
Drives supplier 8D Team on completion of urgent quality issues and provides update to Corporate Quality Assurance / Corporate SQE; drive completion of investigation through task force meetings
Drive continuous improvement and maintain communication with assigned suppliers through quality focus meetings and sharing of lessons learned.
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Drive supplier improvement through assessment and scorecard management. Evaluate the impact of Non-conformance, both internal and external, and assess supplier corrective actions. Assist supplier in preparing and implementing 8D (RCCA), First Article, etc.
Conduct a supplier audit to assess the suppliers’ capability to supply conforming materials/products to our corporation.
the supplier quality engineering and supplier quality management programs.
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Maintain quality records and trackers on relevant platforms and Quality Management Systems (e.g., eNCS, eChecklist), ensuring data integrity and accessibility for audit and review purposes.
Update documents and procedures in Agile in alignment with engineering changes (WDITR), process improvements, or audit findings.
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Responsible for Engineering Change Review, 8D Review, and coordination, interface with downstream as required, e.g., excursion-related, packaging feedback.
Responsible for following up and following through on committed actions/evaluation lots for improvements.
Participate in related risk assessment activities and improvement activities with relevant parties as applicable, e.g., HIRADC, EIA, ROA, FMEA, CI.
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To ensure non-conforming report is prepared and informed superior upon any defective part detected during Incoming, In-Process and Outgoing inspection process.
To ensure on hold or rejected goods are properly identified and segregate with Rejection or On hold note.
To inform superior if detected any part inspection, work instruction or related document not correspondence with actual part and practice.
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Lead and coordinate the Internal Quality Audit Program and ensure that internal and external audits are conducted within the required timelines.
Coordinate corrective and preventive actions arising from audits, inspections, accreditation assessments, incidents, clinical complaints and other quality-related findings.
Collaborate with relevant stakeholders to establish and implement quality standards, accreditation programs, and organizational requirements within the respective operational units.
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