QAQC Manager

Job Summary

Provides strategic, comprehensive site leadership to ensure full compliance with global medical device regulations and ISO standards. This role acts as the official Management Representative, driving continuous QMS improvements, optimizing production quality, and overseeing site regulatory compliance across quality, environmental, and safety frameworks.

Core Responsibilities & Essential Duties

QMS & Compliance Management

• Serve as Site Management Representative for ISO and regulatory affairs.
• Develop and maintain QMS procedures and work instructions compliant with ISO 13485.
• Lead external audits and inspections from regulatory bodies like the FDA, ISO.
• Maintain site certifications, registrations, and manage the documentation control system.

Operational Quality & Inspection

• Manage the testing, inspection, and calibration functions and equipment systems.
• Authorize dispositions for non-conforming materials and products.
• Support engineering with process verification/validation activities and specification building.

Continuous Improvement & CAPA

• Drive product and process improvements using 6 Sigma, Lean, DOE, FMEA, SPC, and Gage R&R.
• Administrate internal quality audits to proactively monitor and reduce process variability.
• Direct customer complaint investigations and manage the end-to-end CAPA process.

Team Leadership & Strategy

• Provide direction and coaching to the QAQC team, conducting performance reviews and personal development.
• Manage and operate within the approved departmental budget.
• Participate in new product launches and manage supplier quality audits/remedial actions.

Requirement:

• Bachelor’s degree in Chemical Engineering, Mechanical/Manufacturing Engineering, Chemistry, Science, or a related technical discipline.
• Minimum of 5–8 years of progressive QA/QC experience, within a medical device or rubber/latex manufacturing environment. At least 3 years in a managerial role
• ISO & Regulatory Expertise: Hands-on experience executing and validating an ISO 13485 compliance cycle is mandatory. Experience dealing with medical device registration bodies is highly preferred
• Technical Skillset: Strong familiarity with statistical process controls (SPC), Failure Mode and Effects Analysis (FMEA), and process validation (IQ/OQ/PQ).
• Languages: Strong written and verbal communication skills in English and Bahasa Malaysia to effectively liaise with international corporate clients and local production teams.

Work Location:

HCM-Hygenic Corporation (M) Sdn Bhd

Plot 6, Lorong Bemban 2, Bemban Industrial Park, 31000 Batu Gajah, Perak.