Senior QA Lead, Post-Market & Regulatory Compliance

Olympus Corporation; Selangor; Presencial; MYR 90.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Learning & development

Health & wellbeing initiatives

Employee assistance

Collaboration with healthcare pros

Quality-focused culture

Descripción de la vacante

Olympus Corporation in Malaysia is seeking a Senior Executive, Quality Assurance to join the QARA team. You will own key QA processes, drive post-market surveillance, and support regulatory compliance within GDPMD requirements.

You will report to the Manager, QARA Malaysia and collaborate across quality, regulatory and healthcare professionals to deliver continuous improvement and robust quality systems.

Formación

• Bachelor-level degree in Science, Engineering, Pharmacy or related field.
• Minimum five years of Quality Assurance experience in the medical device industry.
• Strong knowledge of medical device regulations, quality systems and GDPMD.
• Experience with complaint handling, CAPA, audits and post-market surveillance.
• Excellent analytical, communication and stakeholder management skills.
• Ability to work independently and manage multiple activities.
• Experience with Medcrest and MedC@st is highly regarded; certifications are a plus.

Responsabilidades

• Manage medical device complaints from reporting to investigation and closure.
• Assess complaint reportability and regulatory submissions within timelines.
• Coordinate Field Corrective Actions, recalls, stop-ship actions, containment and disposition.
• Facilitate CAPA investigations, root-cause analysis and action planning.
• Conduct internal audits and support external/regulatory audits.
• Maintain document control systems, quality procedures and training materials.
• Monitor regulatory developments and assess impact on the organisation.
• Support GDPMD compliance and other medical device requirements.

Conocimientos

Quality Assurance

Regulatory compliance

CAPA management

Post-market surveillance

Audits

Stakeholder management

Analytical skills

Educación

Science/Engineering/Pharmacy degree

Herramientas

Medcrest

MedC@st

Descripción del empleo

Olympus Corporation in Malaysia is seeking a Senior Executive, Quality Assurance to join the QARA team. You will own key QA processes, drive post-market surveillance, and support regulatory compliance within GDPMD requirements.

You will report to the Manager, QARA Malaysia and collaborate across quality, regulatory and healthcare professionals to deliver continuous improvement and robust quality systems.