QAQC Manager

HCM-Hygenic Corporation (Malaysia) Sdn Bhd; Batu Gajah; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Group Personal

Job summary

HCM‑Hygenic Corporation (Malaysia) Sdn. Bhd. seeks an experienced QA/QC leader to ensure ISO 13485 alignment, regulatory compliance, and continuous quality improvements across production, environmental, and safety frameworks.

You will drive CAPA, supplier quality audits, and new product launches while mentoring the QAQC team and managing budgetary planning.

Qualifications

• Bachelor’s degree in a technical field is required.
• Minimum 5–8 years of progressive QA/QC experience in medical device or rubber/latex manufacturing.
• At least 3 years in a managerial role.

Responsibilities

• Act as Site Management Representative for ISO and regulatory affairs.
• Develop and maintain QMS procedures and work instructions.
• Lead external audits and inspections by regulatory bodies.
• Maintain site certifications, registrations and document control.
• Oversee testing, inspection and calibration functions.
• Authorize dispositions for non-conforming materials and products.
• Drive process improvements using Six Sigma, Lean, DOE, FMEA, SPC and Gage R&R.
• Conduct internal quality audits and CAPA management.
• Manage QAQC team performance and budget.
• Support new product launches and supplier quality audits.

Skills

English

Bahasa Malaysia

Quality Management

Six Sigma

Lean

SPC

FMEA

IQ/OQ/PQ

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Mechanical/Manufacturing Engineering

Bachelor’s degree in Chemistry

Bachelor’s degree in Science

Tools

ISO 13485

Job description

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.

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

Company Overview

HCM‑Hygenic Corporation (Malaysia) Sdn. Bhd. (The Performance Health Company), is a global consumer branded health and wellness products company and world’s leading distributor of rehabilitation, and recovery providers to the physical and occupational therapy markets, is looking for a suitable candidate.

Values

Our Customer Value Proposition to be the logical choice for Recovery and Rehabilitation Providers and Patients; and our Employee Value Proposition to focus on our values. Our values drive us forward. They provide the framework for making decisions about who we hire and promote and how we get things done.

We are resourceful problem‑solvers who define how we want to make an impact. Start where you are, use what you have, do what you can, dream of a better way and make it happen.

We are interdependent. We rely on each other and collaborate across functions, geographies and businesses. Everyone matters. By trusting one another, we aim high for ourselves, the company and the world.

Perks and Benefits

Medical Dental Group Hospital & Surgical Insurance ; Group Person