Quality Manager

Job Responsibilities

1. Lead and manage the Quality Management System (QMS) in compliance with ISO 13485, IATF 16949, ISO 9001, and ISO 14001 requirements.
2. Oversee overall quality operations including IQC, IPQC, OQC, customer quality, and supplier quality.
3. Handle customer complaints, CAPA, NCR, SCAR, and root cause analysis activities.
4. Lead internal, external, and customer audits.
5. Ensure compliance with medical device manufacturing requirements and automotive quality standards.
6. Support process validation activities including IQ/OQ/PQ, SPC, FMEA, MSA, APQP, PPAP, and control plans.
7. Monitor quality KPIs such as yield, FPY, DPPM, scrap, and customer complaints.
8. Drive continuous improvement initiatives through Lean Manufacturing and Six Sigma methodologies.
9. Lead and develop the Quality team to achieve departmental objectives.

Job Requirements

1. Bachelor's Degree in Engineering, Quality, Biomedical, Manufacturing, or related field.
2. Minimum 8 years of experience in manufacturing quality environment.
3. Minimum 3 years of managerial experience.
4. Experience in medical device and/or automotive manufacturing environment is preferred.

Strong knowledge in:

1. ISO 13485
2. IATF 16949
3. ISO 9001
4. CAPA
5. SPC / MSA / FMEA
6. APQP / PPAP
7. Validation (IQ/OQ/PQ)
8. Root Cause Analysis
9. Strong leadership, communication, and problem-solving skills.
10. Good command of English Mandarin is an added advantage.

Qualifications

1. ISO 13485 and IATF 16949 Lead Auditor certification.
2. Six Sigma Green Belt / Black Belt certification.
3. Experience in cleanroom manufacturing environment is an added advantage.