Senior QA Leader, Medical Devices (ISO 13485 & CAPA)

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 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