Job details
| Location: | |
| Job Type: | Permanent |
| Discipline: | |
| Reference: | HLS/KP/SSQE/231019C |
| Posted: | over 4 years ago |
| Consultant: | Kelvin Pang |
| Consultant Email: | email Kelvin |
| Consultant Phone: |
Job description
Responsibilities
- Manage suppliers to ensure all part quality requirements are met
- Lead supplier qualification activities for new suppliers with Product Manager, Global Supply Chain, Subject Matter Experts, and/or other cross functional team members
- Conduct on-site audits for qualification of new and existing suppliers to ensure supplier’s QMS is meeting ISO standards and where applicable, FDA QSR (GMP)
- Carry out ongoing monitoring of (critical) supplier performance, including periodic audits and periodic quality reports/scorecards
- Continual improvement actions with suppliers to drive quality (e.g. clarification of specification, additional quality requirements, improved specifications)
- Initiate and drive periodic Quality Review meetings with (critical) suppliers
- Drive timely CAPA and customer complaint closure by ensuring suppliers conduct failure analysis and give prompt and comprehensive resolution for defective instrument and/or part failures
- Ensure suppliers conduct failure analysis and give prompt and comprehensive resolution for defective parts (factory and fields)
- Analyse and drive appropriate actions to reduce/eliminate Field Installation and Warranty defectives
- Support all Continual Improvement initiatives/ activities to improve KPIs
- Ensure compliance of operations within area of concern with all relevant EHS regulatory requirement and Company safety policies, procedures and guidelines
Experience
- Degree in Electrical/ Electro-Mechanical/ Mechanical Engineering with at least 3 years’ experience in quality assurance/ supplier quality experience in a manufacturing environment or regulated industry such as medical devices manufacturing
- Strong knowledge in managing suppliers including supplier evaluation and supplier audits
- Experience with problem solving tools such as root cause analysis, FMEA
- Familiar with Statistical Process Controls and Measurement System Analysis
- Ability to read technical drawings
- Must have ISO 9001 working knowledge. Familiar with ISO16949, 13485 and FDA QSR
Please contact Kelvin Pang at +65 6950 0364 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion
EA License no: 16S8066 | Registration no: R1325516
Only successful candidates will be notified.