Senior Executive Quality Assurance

Olympus Corporation; Selangor; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Development opportunities

Health & wellbeing

Employee assistance

Recognition programs

Collaborative team

Quality culture

Job summary

Olympus Corporation in Malaysia is seeking a Senior Executive, Quality Assurance to lead post-market surveillance and QMS activities within the QARA Malaysia team. This role reports to the Manager, QARA Malaysia and focuses on timely resolution of quality issues and regulatory compliance.

You will manage medical device complaints, coordinate CAPA, support internal and external audits, maintain document control and stay abreast of regulatory developments to ensure ongoing GDPMD compliance and

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.
• Ability to work independently and manage multiple activities.
• Experience with Medcrest and MedC@st highly regarded.
• GDPMD, medical device regulation, internal auditor or ISO certifications 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

Regulatory compliance

Analytical skills

Stakeholder management

Education

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.

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.
• Reward and recognition programmes.
• Opportunities to collaborate with experienced Quality, Regulatory and healthcare professionals.
• A welcoming culture focused on quality, compliance and continuous improvement.

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 or medical 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, prioritise 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.

In the meantime, follow us on:

• LinkedIn - Olympus Corporation
• Company website - www.olympus.com.au

“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.”