Supplier Quality Management

Job Scope
- Supplier Quality Management: Develop, implement, and maintain supplier quality assurance programs to ensure compliance with ISO-13485. Oversee and monitor the quality of materials, components, and services provided by suppliers to ensure compliance with company standards, specifications, and ISO7 cleanroom requirements.
- Supplier Audits: Plan and conduct regular audits at supplier facilities to evaluate processes, quality control systems, and compliance with contractual, regulatory, and ISO7cleanroom standards. Own driving supplier prepares for client visits.
- Supplier Qualification: Lead the qualification and onboarding of new suppliers, including risk assessments, quality agreements, and validation processes.
- Travel: Travel to supplier sites, both domestically and internationally, to perform audits, resolve quality issues, and build strong supplier relationships.
- Supplier Collaboration: Work closely with suppliers to address quality issues, implement corrective actions, and drive continuous improvement in their processes, particularly inISO7 cleanroom environments.
- Performance Monitoring: Monitor and evaluate supplier performance through key performance indicators (KPIs), such as defect rates, on-time delivery, and compliance metrics.
- Non-Conformance Management: Drive suppliers investigate supplier-related nonconformances, issue and manage Supplier Corrective Action Report (SCAR),coordinate root cause analysis, and implement corrective and preventive actions (CAPA).
- Cleanroom Compliance: Ensure suppliers meet ISO7 cleanroom standards, including contamination control, material handling, and process validation, to support high-quality production.
- Quality Assurance: Develop and implement supplier quality metrics, scorecards, and performance evaluations to ensure consistent quality standards.
- Documentation: Maintain detailed records of supplier audits, quality performance, corrective action plans, Approved Supplier List, and ISO7 cleanroom compliance, ensuring adherence to industry standards.
- Cross-Functional Collaboration: Partner with procurement, engineering, and manufacturing teams to align supplier quality requirements with production needs, including cleanroom specifications
- Risk Management: Identify and mitigate risks in the supply chain, including supplier-related quality issues and potential disruptions.
- Communication: Communicate effectively with suppliers in Chinese (Mandarin) to facilitate clear discussions, resolve issues, and negotiate quality improvements.

Requirement
- Bachelor’s degree in Engineering, Supply Chain Management, Quality Management, or arelated field.
- Minimum of 3 years of experience in supplier quality management or a related role, preferably within the medical device or consumables industry.
- Proven experience conducting supplier audits and managing supplier relationships.
- Good knowledge of working in an ISO7 cleanroom environment, including contamination control and cleanroom protocols.
- Strong understanding of quality management systems, such as ISO 9001 and ISO7cleanroom standards.
- Familiarity with auditing processes and supplier evaluation methodologies
- Knowledge of manufacturing processes and quality control techniques, particularly in clean room settings
- Willingness and ability to travel frequently (up to 50% of the time) to supplier sites, both domestically and internationally.
- Build relationships with suppliers and collaborate with internal teams.
- Certifications such as Certified Supplier Quality Professional (CSQP), Six Sigma, or Lean Manufacturing are a plus.

Working day
- Monday to Friday 8.30AM to 5.30PM

Pay: RM2,866.76 - RM6,000.00 per month

Work Location: In person