Senior QAQC Manager — Medical Device Quality & Compliance

HCM-Hygenic Corp (M) Sdn Bhd

Ipoh

On-site

MYR 180,000 - 300,000

Full time

32 hours ago

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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

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

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