QA/QC EXECUTIVE

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

Job summary

Dispo-Med Malaysia Sdn Bhd is seeking a Quality Engineer to ensure processes and products meet CE/FDA/ISO13485 requirements. You will participate in design reviews and apply CAPA and risk assessment methods across the product lifecycle.

The role requires a strong foundation in quality management, problem solving, and cross-functional communication within a medical devices environment.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, or related field.
• Familiarity with CE, FDA, ISO 13485 and design control principles.
• Experience in root cause analysis, risk assessments, and CAPA implementations.
• Excellent problem-solving, organizational and communication skills.

Responsibilities

• Ensure all processes, systems, and products meet quality standards and regulatory requirements.
• Involved in various stages of the product lifecycles.
• Maintain safety, efficiency, and reliability of medical devices produced in the facility.

Skills

Quality management

Regulatory knowledge

Root cause analysis

CAPA

Problem solving

Project management

Communication

Education

Bachelor's degree in Engineering or Life Sciences

Job description

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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.