QA Operations Manager

Role Responsibilities

• Provide leadership and technical expertise on Quality Assurance requirement.
• Focus on continuous improvements including usage of appropriate testing tools, test techniques, test automation.
• Gather and present quality assurance metrics and performance to Group Senior QA Operations Manager.
• Involve or participate in design control, risk analysis and process validation as quality assurance function.
• Review customers’ requirements to ensure that the necessary criteria and provisions are included in quality and process plans.
• Direct the development of the rework standard, QA methodology and systems. Driving and improving the QA team in quality assurance.
• Ensure that conformity of the devices is appropriately checked, in accordance with the quality management system, and regulatory requirements under which the devices are manufactured, before a device is released.
• Involve in management review, including reporting on the effectiveness of quality management system to top management and ensuring any need for improvement is addressed.
• Ensures that target agreed for the KPI’s under the responsibility of the position are achieved.
• Promote awareness of applicable regulatory and QMS requirements throughout the organization.
• Ensure that all relevant process for the QMS is documented.
• Involvement in risk management activities including identify new risks, estimate probability of risk and impact, classify risk, recommend mitigation action / risk control measures, assist in prioritizing risks, review and evaluate the medical benefit of the individual and overall residual risk, evaluate overall residual risk. Maintain the risk management files and ensure that it is always up to date.
• Other duties assigned by the superior.

Role Requirements

• Minimum 5 years of professional experience in quality management systems relating to medical devices.
• At least a university degree in scientific discipline.
• Strong knowledge of quality standards, regulatory requirements, and audit processes.
• Excellent leadership, problem-solving, and analytical skills.
• Strong communication and interpersonal abilities.

Submit your resume to
hr@karex.com.my
We regret that only shortlisted candidates will be notified.
Thank you and have a nice day!