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

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

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