Internal Processes and Reporting
- Maintain overall both Singapore and regional Business Entities’ Quality System through review, revision and update of quality management procedures and documentation which comprises of System Procedures (SPs), Standard Operating Procedures (SOPs) and Work Instructions (WI).
- Work with process owner(s) to establish new or revision of quality management processes and procedures.
- Review quality management processes to improve its effectiveness and efficiency.
- Plan and conduct yearly routine internal audits and inspections, scheduled quality audits, mock recalls and traceability exercises and follow up with audit report and ensure audit closure.
- Plan, prepare and coordinate external audits by regulatory bodies and customers and to track and monitor follow-up actions required to close out the audits.
- Track and manage deviations, CAPAs and customer complaints ensuring effective resolution through verification of the effectiveness of corrective and/or preventive actions.
- Lead investigation of all quality deviations and/or non-conformances detected and work with stakeholder(s) on root cause analysis and eliminate such deviations.
- Prepare and conduct Management Review with input from stakeholders and follow up with action items for closure.
- Monitor and track all QA deliverables and activities and conduct necessary follow through until closure to ensure QA KPI targets are met.
- Address quality and compliance related queries and concerns from internal stakeholders, customers and regulatory bodies and advice process owners on documentation related issues.
- Track and monitor both Singapore and Regional KPIs including Quality Assurance performance and develop monthly and/or quarterly analysis and reports for reporting to Management.
Project Support, Training and Continuous Improvement
- Provide QA support to new business development projects for potential or new onboarding customers and ensure quality requirements from both regulatory authorities and customers are met.
- Review contractual quality requirements for new and existing customers to ensure quality compliance and ensure quality objectives are met.
- Conduct training (initial training and refresher training) on international standards such as ISO 9001, ISO 13485, GDPMDS, QA internal training, quality related programs and quality management procedures
- 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 for continuous improvement including monthly progress tracking.
Others
- Carry out any other duties assigned from time to time by Head of QRA.
Requirements
- Bachelor's degree Science, Engineering-related field or equivalent experience
- Proficient in ISO 9001: 2015 / ISO 13485: 2016 /GDP/GDPMDS/GMP requirements
- Certified ISO 9001: 2015 / ISO 13485: 2016 Lead/Internal Auditor experience
- Familiarity with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
- Proficient in MS Office Applications (MS Word, Excel, Powerpoint)
- 2-3 years of relevant experience preferred.
- Strong analytical skills and attention to details.
- Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional teams.
- Proficiency in data analysis and reporting tools.
- Problem-solving mindset and the ability to drive continuous improvement.
