QA Engineer (Medical Device)

Agensi Pekerjaan Minde Group Sdn Bhd; Johor Bahru; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading recruitment agency in Malaysia seeks a quality management professional to oversee manufacturing activities, ensuring compliance with quality systems and regulations. Candidates should hold a Bachelor's degree in Engineering and possess strong communication skills in English. Proficiency in Microsoft Office is required. Responsibilities include supporting validation activities, leading quality investigations, and participating in continuous improvement initiatives. This is an opportunity to contribute to maintaining high-quality standards within a growing organization.

Qualifications

• Bachelor's degree in Engineering (Manufacturing, Materials, Biomedical, or a related discipline).
• Strong verbal and written communication skills with good proficiency in English.
• Proficiency in Microsoft Office applications.

Responsibilities

• Provide quality oversight to ensure compliance with internal quality systems.
• Support process and equipment validation activities.
• Lead investigations of quality issues using root cause analysis.
• Prepare and approve quality documentation.
• Collaborate with manufacturing teams for improvement initiatives.
• Support supplier quality activities.
• Investigate complaints for post-market surveillance.
• Support internal and external audits.
• Communicate quality requirements to manufacturing personnel.
• Participate in Lean and Kaizen initiatives.

Skills

Strong verbal and written communication skills

Proficiency in Microsoft Office

Education

Bachelor's degree in Engineering

Job description

Job Description

• Provide quality oversight to ensure manufacturing activities comply with internal quality systems, applicable regulatory requirements, and customer expectations.
• Support process and equipment validation activities, including review of validation protocols, reports, controls, and data integrity.
• Lead or support investigation of quality issues using structured root cause analysis (RCA) methodologies and drive effective corrective and preventive actions (CAPA).
• Prepare, review, and approve quality documentation such as control plans, inspection procedures, validation documents, and related records.
• Collaborate with manufacturing teams to support continuous improvement initiatives while ensuring product quality and compliance are maintained.
• Support supplier and component quality activities, including evaluation of supplier performance and quality-related issues, where applicable.
• Support post-market surveillance (PMS) activities by investigating complaints, identifying trends, and translating findings into preventive and improvement actions.
• Support internal and external audits to ensure effective implementation of quality systems at the manufacturing site.
• Communicate quality requirements clearly to manufacturing personnel and elevate quality risks or non-conformances as required.
• Participate in Lean, Kaizen, and other quality or process improvement initiatives with cross-functional teams.

Requirements

• Bachelor's degree in Engineering (Manufacturing, Materials, Biomedical, or a related discipline).
• Strong verbal and written communication skills with good proficiency in English.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook, and related tools).