QA/QC EXECUTIVE

Dispo-Med (Malaysia) Sdn Bhd; Shah Alam; On-site; MYR 60,000 - 90,000; Full time

Job summary

Dispo-Med (Malaysia) Sdn Bhd seeks a Quality Engineer to ensure processes and products meet quality standards and regulatory requirements. You will be involved across product lifecycles and help maintain safety, efficiency, and reliability of medical devices produced in the facility.

The role requires a Bachelor's degree in engineering or life sciences, 3+ years in quality engineering (medical devices preferred), strong knowledge of QMS, and experience with CAPAs and design reviews.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, or related field.
• Minimum 3 years related working experience in quality engineering or a related role, preferably in the medical devices industry.
• Strong knowledge of quality management systems, regulatory requirements (eg: CE, FDA, ISO 13485), and relevant industry standards.
• Familiarity with design control principles and experience in participating in design reviews.
• Solid understanding and manufacturing processes, quality control methods, and statistical techniques.
• Experience in conducting root cause analysis, risk assessments, and implementing corrective and preventive action (CAPAs).
• Excellent problem-solving skills and the ability to analyze complex situations and make strong decisions.
• Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Excellent communication skills, both written and verbal, with the ability to effectively communicate with cross-functional teams.

Responsibilities

• To ensure that all processes, systems, and products meet or exceed quality standards and regulatory requirements.
• Involved in various stages of the product lifecycles.
• Maintaining the safety, efficiency, and reliability of medical devices produced in the facility.

Skills

Quality management

Regulatory compliance

Design control

CAPA

Root cause analysis

Risk assessment

Education

Bachelor's degree in engineering or life sciences

Job description

To ensure that all processes, systems, and products meet or exceed quality standards and regulatory requirements.

Involved in various stages of the product lifecycles.

Maintaining the safety, efficiency, and reliability of medical devices produced in the facility.

Job Requirement and Qualification

Bachelor's Degree in Engineering, Life Sciences, or related field.

Minimum 3 years related working experience in quality engineering or a related role, preferably in the medical devices industry.

Strong knowledge of quality management systems, regulatory requirements (eg: CE, FDA, ISO 13485), and relevant industry standards.

Familiarity with design control principles and experience in participating in design reviews.

Solid understanding and manufacturing processes, quality control methods, and statistical techniques.

Experience in conducting root cause analysis, risk assessments, and implementing corrective and preventive action (CAPAs).

Excellent problem-solving skills and the ability to analyze complex situations and make strong decisions.

Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.

Excellent communication skills, both written and verbal, with the ability to effectively communicate with cross-functional teams.