Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

1. 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.

2. 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.

3. 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.