Job Description:
Internal Processes and Reporting
- Establish and maintain Quality Management System in both local and SEA region.
- Develop or update procedures and SOPs for quality system process to ensure continuous process improvement is met.
- Support audit readiness, conduct and prepare for regulatory or external audit as well as internal quality audits to ensure timely execution according to defined schedules.
- Execute recall or field corrective actions and other post-market surveillance activities within impacted countries in the SEA region.
- Participate in handling non-conformity, corrective and preventive actions, documentations, supplier quality across the organization’s sites.
- Assist administration of management review process, including maintaining compliance to quality system data metric analysis, monitor and trend quality indicators to proactively report or escalate issues to QRA manager.
- Track and monitor both Singapore and Regional KPIs including QA performance and develop monthly and/or quarterly analysis and reports for reporting to Management.
- Execute other tasks and projects, as assigned by QRA manager.
Project Support, Training and Continuous Improvement
- Provide QA support to new business development projects for potential or new onboarding customers.
- Conduct training (both internal and refresher training) on standards and procedure, quality related programs and quality management procedure.
- Conduct process mapping and identify areas of improvement and implement steps required to improve processes within QA and other functions.
- Responsible for planning and implementation of QA related projects.
Minimum Qualifications:
- Degree holder in Life science, biomedical engineering-related field or equivalent experience.
- Strong attention to details.
- Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
- Able to converse in proficient Chinese.
- Problem-solving mindset and the ability to drive continuous improvement.
- Familiar with GDP and GDPMDS is a plus.
- Familiar with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
- Having quality assurance experience is a plus.
