Quality Assurance Manager

The Hygenic Company LLC; Ipoh; On-site; MYR 180,000 - 300,000; Full time

Job summary

The Hygenic Company LLC in Malaysia is seeking a QAQC Manager to lead the site's quality management system, ensuringISO 13485 compliance, QMS maintenance, and regulatory adherence. You will oversee CAPA, audits, supplier quality, and product release, driving a culture of defect reduction and process improvement across manufacturing operations.

You will establish, monitor and continuously improve QMS processes, lead evidence-based investigations, and coordinate management reviews to assure

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.

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 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 nonconformance, CAPA and investigation processes with thorough, data-driven root-cause investigations.
• 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, linking trends to CAPA and customer audits.
• Manage supplier quality performance, qualification, audits, quality agreements and SCARs.
• Own the site audit readiness plan and verify effectiveness of audit corrective actions.
• Replace informal training with standardized SOP certifications and complete the skills matrix for quality-critical roles.
• Train operators on defect recognition, in-process checks and reaction plans; verify training effectiveness.
• Ensure inspection, measuring and test equipment are controlled and calibrated for quality decisions.
• Verify Device History Records and production records, and oversee final 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.

Skills

ISO 13485

CAPA

PFMEA

Root cause

Data analysis

Leadership

Quality management

English fluency

Education

Bachelor's in Engineering/Science

ASQ CQE/CMQ/OE

Job description

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.

• 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.