Quality Engineer - #1111716

Responsibilities:

• Maintain updated and accurate documents and records on ISO 9001, 14001 and 13485 system (includes Quality Manual, Procedures, Work Instructions, Forms, etc.) to ensure system compliance and ready for Management Review.

• Plan and conduct internal and external audits to ensure readiness of all sections for third party certification body, management review and customer audits.

• Coordinate with internal stakeholders to participate in customer or supplier audits for compliance

• Review audit findings and develop action plans to drive continuous improvements.

• Generate and review quality reports on suppliers’ performance and work with suppliers to address non-conforming materials, and drive for continuous improvement.

• Issue and follow up on Supplier Corrective Action Request (SCAR) to suppliers, monitor and review SCAR effectiveness for timely closure.

• Support the qualification of new suppliers to maintain a healthy pipeline of qualified suppliers to meet production requirements.

• Maintain and conduct regular review of calibration and preventive maintenance for equipment

• Responsible for quality issues arising from production and customer feedback, and collaborate with the production team to address internal process issues and implement corrective actions to resolve customer complaints with proper documentation.

• Responsible for timely closure of Corrective and Preventive Actions (CAPA), non-conformance investigation report and customer complaints and, publish reports on quality performance.

• Lead the Material Review Board (MRB) meeting involving members from production, engineering and quality departments to conduct root cause analysis, address quality issues, implement corrective actions and review its effectiveness.

• Lead the team of QC inspectors in the inspection of parts for conformity in accordance with relevant drawing requirements.

Requirements:

• Diploma in quality management / Engineering / Manufacturing or related field

• Minimum 3 to 5 years of relevant working experience in handling audits and ISO documentation in manufacturing industries.

• Knowledge in Supplier Management

• Knowledge of quality Management Standards such as ISO 9001, 14001, 13485 and ISO 22301.

• Knowledge in Potential Failure Mode Effect Analysis (PFMEA), Control Plans .and Gage Repeatability & Reproducibility (GR&R)

• Familiar with 8D and 5W problem solving methodology.

By submitting any application or résumé to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.

Under the revised Employment Agencies Licence Condition 5(b), employment agencies (EAs) are required to collect the personal data (e.g. NRIC, FIN) of applicants referred to employers for permanent or contract job positions of at least 6 months with a fixed monthly salary of $3,300 and above. PDPA requirements on collection, use and disclosure of personal data are not applicable to EAs that are collecting such information, as it is a regulatory requirement.

We regret to inform you that only shortlisted applicants would be notified.

Dynamic Human Capital Pte Ltd | EA License No.: 12C6253

Han Tze Jian | EA Personnel No.: R1658384