Responsibilities and Authorities
- Developing, implementing, and maintaining the Quality Management System in compliance with relevant regulatory standards (e.g., FDA, ISO 13485).
- Conducting internal audits and assessments to ensure compliance with quality standards and identifying areas for improvement.
- Collaborating with multi-functional teams to maintain quality objectives, key performance indicators, and metrics.
- Tracking and analyzing quality data to identify trends, issues, and opportunities for process improvement. Ensure accurate completion of QMS events (e.g Change Control, Deviation, CAPA) and related documentation.
- Facilitating and participating in management reviews to drive continuous improvement efforts.
- Handle regulatory or customer inspections and audits, as necessary.
- Assisting in the development and delivery of training programs related to the Quality Management System.
- Lead document periodic review by coordinate with internal parties to maintain and update all necessary documentation to align with system requirements. Exercise document control for all management system.
- Establishing site policies and procedures in maintaining the Quality Management System.
- Identify and implement process improvement opportunities, cost improvement, and monitor the efficiency.
- Handle ad hoc assignment as required.
Qualification
- Bachelor's degree in engineering or a related field.
- Solid understanding and experience with relevant quality standards and regulations (e.g., FDA QSR, ISO 13485. MDSAP).
- Previous experience working in the medical device industry and familiarity with QMS requirements specific to this industry.
- Proficiency in conducting internal audits and assessments.
- Certified ISO13485:2016 internal auditor is preferred.
Experience
- A minimum of 3-5 years’ proven experience in medical device (IVD) manufacturing environment.
- Experience in a regulated industry preferred.
4. Competencies
- Capacity to work both independently and in a team-orientated environment.
- Strong and effective communication and interpersonal skills to collaborate with multi-functional teams.
- Strong attention to detail and ability to work with complex documentation.
- Excellent analytical and problem-solving skills.
