MedTech QA Officer - QMS Lead, Risk & Audit

Nagoya Plastic Industry Sdn Bhd; Lunas; On-site; MYR 50,000 - 73,000; Full time

Benefits offered by this job

Medical

Yearly Bonus

Transport Allowance

Training Program

Job summary

Nagoya Plastic Industry Sdn. Bhd. is seeking a Quality Assurance Officer to maintain QMS documentation and lead risk management activities aligned with ISO 9001, ISO 13485, and ISO 14971.

You will manage QA/QC for the MedTech Section, ensure regulatory compliance, and drive CAPA and root cause analysis across cross-functional teams. Responsibilities include internal QMS audits, device history records review, and generation of corrective actions to support smooth production and product releases.

Qualifications

• At least 2 years of QA experience.
• Familiar with ISO 9001, ISO 13485 and QMS requirements.
• Familiarity with quality tools such as FMEA, CAPA and root cause analysis.
• Able to conduct internal QMS Audit.
• Good writing and communication skills.
• Able to work independently and collaborate with cross-functional teams.

Responsibilities

• Maintain and update QMS documentation in compliance with ISO 9001, ISO 13485 and regulatory requirements.
• Lead or participate in risk management activities (e.g. process FMEAs) per ISO 14971.
• Manage QA/QC activities for MedTech Section to ensure specs and regulatory compliance.
• Guide QA/QC personnel to perform daily inspection/test activities per QMS docs.
• Ensure inspection methods and documentation support production and issue resolution.
• Prepare and review Device History Records and recommend Final Product Release.
• Participate in customer complaint investigations and perform root cause analysis.
• Review non-conforming products and determine disposition; track actions.
• Act as internal auditor to ensure ISO 13485 compliance and support audits.
• Prepare and maintain documentation for pre-market regulatory requirements.

Skills

FMEA

CAPA

Root cause analysis

QMS audit

Technical writing

Tools

ISO 9001

ISO 13485

Job description

Nagoya Plastic Industry Sdn. Bhd. is seeking a Quality Assurance Officer to maintain QMS documentation and lead risk management activities aligned with ISO 9001, ISO 13485, and ISO 14971.

You will manage QA/QC for the MedTech Section, ensure regulatory compliance, and drive CAPA and root cause analysis across cross-functional teams. Responsibilities include internal QMS audits, device history records review, and generation of corrective actions to support smooth production and product releases.