Senior Supplier Quality Engineer
On-siteWoodlands, Singapore
Job Summary
Lead supplier quality activities to monitor compliance with Quality System Regulations, FDA standards, and ISO requirements while driving continuous improvement for purchased parts and services. Manage the selection, evaluation, and qualification of new suppliers, including leading audits, failure investigations, and CAPA implementation to ensure process standardization. Participate in new product development teams to assure reliable product design, manage risk through FMEA, and facilitate the transfer of suppliers from development to production. Maintain goals and metrics for existing products, regularly report progress, and provide training to ensure team consistency with quality procedures.
Required Qualifications
- Experience collaborating with cross-functional product development and operational teams
- Strong communication and negotiation skills
- Experience with Quality, Project Management, and Process Engineering methodologies and tools
- Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities
- Demonstrated capability in successfully managing and leading change
- Practice identifying, mitigating, and resolving risks
- Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities
- Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments
- Experience with electronic product life cycle (PLM) systems such as Agile or SAP
- Ability to travel domestically and internationally as needed. Estimate 25% of the time.
Desired Qualifications
- BS or equivalent in a technical discipline with 5+ years of experience
- MS or PhD in a technical discipline with 3+ years of experience
- Practical experience in FDA and ISO regulated environments is a plus
- Experience with statistical analysis packages such as JMP and Minitab is a plus
- Experience working in a regulated environment, in-vitro diagnostics preferred
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