Senior QA Executive - Medical Devices, Post-Market & CAPA

Olympus Corporation; Petaling Jaya; On-site; MYR 90,000 - 180,000; Full time

Benefits offered by this job

Competitive salary package

Learning and professional development

Health and wellbeing initiatives

Employee assistance and wellbeing supp

Job summary

Olympus Corporation in Malaysia is seeking a Senior Executive, Quality Assurance to join the QARA team. You will own post-market surveillance, drive quality processes and ensure regulatory compliance across medical devices.

You will lead CAPA, audits and document control, supporting continuous improvement and patient safety. Reporting to the Manager, QARA Malaysia, you will collaborate with cross-functional teams, manage investigations, regulatory submissions, and maintain GDPMD adherence to

Qualifications

• A degree in Science, Engineering, Pharmacy or a related discipline.
• At least five years’ Quality Assurance experience in the medical device industry.
• Strong knowledge of medical device regulations, quality systems and GDPMD requirements.
• Experience in complaint handling, CAPA management, audits and post-market surveillance.
• Strong analytical, communication and stakeholder management skills.
• The ability to work independently, prioritize effectively and manage multiple activities.
• Experience with Medcrest and MedC@st will be highly regarded.
• GDPMD, medical device regulation, internal auditor or ISO certifications will be advantageous.

Responsibilities

• Managing medical device complaints from initial reporting through to investigation and closure.
• Assessing complaint reportability and completing regulatory submissions within required timelines.
• Coordinating Field Corrective Actions, product recalls, stop-ship activities, containment actions and product disposition.
• Facilitating CAPA activities, including investigations, root-cause analysis and action planning.
• Conducting internal audits and supporting external and regulatory audits.
• Maintaining document control systems, quality procedures and training materials.
• Monitoring regulatory developments and assessing their impact on the organisation.
• Supporting compliance with GDPMD and other applicable medical device requirements.

Skills

Quality assurance

Complaint handling

CAPA management

Audits

Post-market surveillance

Stakeholder management

Analytical

Communication

Education

Bachelor's degree in Science/Engineering/Pharmacy

Tools

Medcrest

MedC@st

Job description

Olympus Corporation in Malaysia is seeking a Senior Executive, Quality Assurance to join the QARA team. You will own post-market surveillance, drive quality processes and ensure regulatory compliance across medical devices.

You will lead CAPA, audits and document control, supporting continuous improvement and patient safety. Reporting to the Manager, QARA Malaysia, you will collaborate with cross-functional teams, manage investigations, regulatory submissions, and maintain GDPMD adherence to