QAQC Manager

HCM-Hygenic Corp (M) Sdn Bhd; Ipoh; On-site; MYR 180,000 - 300,000; Full time

Job summary

HCM-Hygenic Corp (M) Sdn Bhd in Ipoh, Malaysia, seeks a QAQC Manager to lead the site Quality Management System compliant with ISO 13485 and FDA QMSR. The role oversees manufacturing quality, supplier quality, CAPA, audits and product release, driving continuous improvement and quality ownership across the site.

The ideal candidate has a Bachelor's in engineering/science, 7+ years in regulated manufacturing, and proven leadership to build robust quality programs, with strong data analysis and

Qualifications

• Requires a Bachelor's degree in a related field and 7+ years in regulated manufacturing.
• Experience implementing ISO 13485 QMS and CAPA processes.
• Proven audit remediation and supplier quality oversight.

Responsibilities

• Maintain and improve the site QMS in accordance with ISO 13485 and regulatory requirements.
• Lead CAPA governance and root-cause investigations with data-driven decisions.
• Oversee supplier quality performance, audits and quality agreements.
• Drive audit readiness and support customer/certification audits.
• Train operators and ensure calibrated inspection equipment is used.

Skills

Quality leadership

ISO 13485

CAPA & RCA

Statistical analysis

PFMEA

Audit management

Training & SOPs

Documentation control

Cross-functional collab

English fluency

Education

Bachelor's degree in Engineering/Science

Master's or CQE/CMQ/OE

Tools

PFMEA

SPC

QMS software

Job description

Position Summary

The QAQC Manager is the primary quality representative for the HCM Malaysia site, responsible for establishing, implementing, maintaining and continuously improving the Quality Management System in compliance with ISO 13485, the FDA Quality Management System Regulation (QMSR), applicable regulatory and customer requirements, and Performance Health quality policies. The role provides quality oversight of manufacturing operations, supplier quality, complaint handling, CAPA, audits and product release. The Quality Assurance Manager leads priorities in audit readiness, in-process control, traceability, CAPA and root-cause discipline, and scrap and complaint reduction, while building quality ownership across the site.

Essential Duties & Responsibilities

• Maintain and improve the site QMS in accordance with ISO 13485, FDA QMSR and applicable regulatory requirements.
• Establish the site QMS charter and document hierarchy, and ensure procedures, work instructions, specifications and records are established, reviewed and controlled.
• Provide independent quality oversight of manufacturing operations and verify that processes remain in a validated and controlled state.
• Establish in-process QC at critical process steps and ensure first-piece, last-piece and final inspection activities are effective.
• Deploy SPC on the top three critical-to-quality (CTQ) parameters per product family, with control limits, trained operators and reaction plans.
• Build and maintain a defect library and visual aids (accept/reject standards) at the point of use.
• Refresh the PFMEA for top product families and link identified risks to shopfloor control plans.
• Deploy layered process audits and promote error-proofing in manual-intensive operations.
• Drive reduction of defects, scrap, rework, complaints and nonconforming product.
• Manage the nonconformance, CAPA and investigation processes, ensuring root cause investigations are thorough and data-driven.
• Establish and chair a CAPA governance board that risk-ranks CAPAs, defines effectiveness checks and tracks closure rate monthly.
• Oversee complaint handling and customer quality, ensuring timely investigation and closure, linking complaint trends to CAPA, and supporting customer audits and issue resolution.
• Manage supplier quality performance, qualification, audits, quality agreements and SCARs.
• Own the site audit readiness plan, lead preparation for customer, certification and regulatory audits, and verify that audit corrective actions are effective.
• Replace informal on-the-job training with standardized SOP certifications and documented floor sign-offs, and complete the skills matrix for quality-critical roles.
• Train operators, including the temporary workforce, on defect recognition, in-process checks and reaction plans, and verify training effectiveness.
• Ensure inspection, measuring and test equipment is controlled and calibrated, and that only approved and calibrated equipment is used for quality decisions.
• Verify Device History Records and production records, and oversee final review and release of finished product.
• Lead Management Review and monthly quality and RCA reviews; report QMS performance and KPIs
• Promote continuous improvement and quality ownership through Lean, 5S and Kaizen defect-prevention initiatives.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing, Regulatory Affairs, or a related field.
• Master's degree or ASQ CQE, CMQ/OE or equivalent certification preferred.
• 7+ years of quality experience in a regulated manufacturing environment.
• 3+ years of supervisory or management experience.
• Experience implementing and maintaining an ISO 13485 QMS, CAPA, audits, complaint investigations and root cause analysis.
• Preferred: medical device manufacturing; rubber, latex, polyisoprene or polymer manufacturing; FDA, MDSAP and customer audit experience; SPC and process validation.
• Experience leading audit remediation and quality culture transformation.
• Experience establishing clear quality authority within manufacturing.
• Experience improving CAPA effectiveness and investigation quality.
• Experience implementing SPC and process monitoring programs.
• Experience improving traceability and genealogy systems.
• Experience supporting large-scale manufacturing transfers and process equivalency.

Skills & Technical Knowledge

• Strong knowledge of ISO 13485 and medical device requirements.
• Expertise in CAPA, root cause analysis and risk management, including ISO 14971 and PFMEA.
• Ability to interpret quality data and statistical trends.
• Hands-on leadership and the ability to perform detailed quality work.
• Ability to make independent, risk-based quality decisions.
• Ability to drive compliance through execution, not documentation alone.
• Demonstrated ability to build quality ownership and accountability.
• Clear communication across manufacturing, engineering, supply chain and regulatory teams.
• Fluency in English; Bahasa Malaysia and/or Chinese an advantage.