QA/QC EXECUTIVE

Primary 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.

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.