QA Officer

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

This role involves maintaining and updating Quality Management System (QMS) documentation in compliance with ISO 9001, ISO 13485 and applicable regulatory requirements, with a focus on continual improvement. You will lead or participate in risk management activities such as process FMEAs in accordance with ISO 14971, and manage QA/QC activities for the MedTech Section to ensure product specifications, customer requirements and regulatory compliance are consistently met.

Key responsibilities

Maintain and update QMS documentation in compliance with ISO 9001, ISO 13485 and applicable regulatory requirements and continual improvement of the QMS

Lead or participate in risk management activities (e.g. process FMEAs) in accordance with ISO 14971

Manage QA/QC activities of the MedTech Section to ensure product specifications, customers and applicable regulatory requirements are consistently met

Guide QA/QC personnel to ensure daily inspection and/or test activities are performed effectively and according to QMS documents, and maintain products identification and traceability

Ensure inspection methods, quality controls and documentation are properly established to support smooth production operations and resolve quality issues effectively

Prepare and review Device History Records and recommend Final Product Release

Participate actively in customer complaint investigations and conduct root cause analysis to identify effective corrective and preventive actions

Review non-confirming products and determine appropriate disposition according to quality requirements, analyse trends and follow up on improvement actions

Act as an internal auditor to ensure compliance with ISO 13485, support third-party and customer audits and assist in audits closure activities

Prepare and maintain documentation for pre-market regulatory requirements and interface with authorized representative or regulatory authority

About you

At least 2 years working experience in QA

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 effectively with cross-functional teams

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• How many years' experience do you have as a Quality Assurance Officer?
• Which of the following types of qualifications do you have?

Chemicals & Plastics Manufacturing 101-1,000 employees

Nagoya Plastic Industry Sdn. Bhd. is specialized in plastic injection moulding industry and is a one stop manufacturing for multi national corporations (MNC) in Electronic & Electrical, Aerospace, Medical Devices Automotive Industries. Its core business that is plastic injection moulding and covers wide range of services including mould design, tooling fabrication, spray painting, hot foil stamping, silk screening, tampo printing, heat stacking, ultra-sonic, induction and sub assemblies.

Email Address: [e-mail]

Certification attains : ISO 9001 QMS, ISO/TS 16949 Automotive QMS, AS 9100 Aerospace QMS, ISO 13485 Medical Devices QMS, ISO 14001 EMS.

Nagoya Plastic Industry Sdn. Bhd. is specialized in plastic injection moulding industry and is a one stop manufacturing for multi national corporations (MNC) in Electronic & Electrical, Aerospace, Medical Devices Automotive Industries. Its core business that is plastic injection moulding and covers wide range of services including mould design, tooling fabrication, spray painting, hot foil stamping, silk screening, tampo printing, heat stacking, ultra-sonic, induction and sub assemblies.

Email Address: [e-mail]

Certification attains : ISO 9001 QMS, ISO/TS 16949 Automotive QMS, AS 9100 Aerospace QMS, ISO 13485 Medical Devices QMS, ISO 14001 EMS.

Perks and benefits Medical Yearly Bonus, Transport Allowance, Training Progra

What can I earn as a Quality Assurance Officer