Senior Executive Quality Assurance

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

We are seeking to appoint a full-time Senior Executive, Quality Assurance to join our Quality Assurance & Regulatory Affairs team in Malaysia.

Reporting to the Manager, QARA Malaysia, you will be accountable for the effective delivery of post-market surveillance and Quality Management System activities. You will provide dedicated ownership of key Quality Assurance processes, support the timely resolution of quality issues and contribute to sustained regulatory compliance and continuous improvement.

Your key responsibilities will include:

• 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.

What we are looking for:

You will consider yourself to be a proactive, detail-oriented and quality-focused individual with:

• 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.

About Olympus:

Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that makes a positive contribution to society.

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

Our commitment to customers and our social responsibility is the cornerstone of everything we do.

Why work at Olympus?

At Olympus, we are dedicated to fostering a high performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact, and Empathy form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.

At Olympus, you will have the opportunity to contribute to a purpose-led organisation where quality and patient safety are central to our work.

We offer:

• A competitive salary package.
• Learning and professional development opportunities.
• Health and wellbeing initiatives.
• Employee assistance and wellbeing support.
• Opportunities to collaborate with experienced Quality, Regulatory and healthcare professionals.
• A welcoming culture focused on quality, compliance and continuous improvement.

“We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.”