The Supply Quality Engineer will be based in Austin, TX. In this position, you will beResponsible for supplier development in a manufacturing or service process; works with suppliers to continuously improve performance, implement process controls and develop quality assurance plans.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do:
- Supplier Selection---Select the suitable supplier with joint-effort with sourcing on aspects of quality, capability, pricing, delivery, environment, society regulation, etc. against customer requirements.
- Supplier Qualification---Implement the new supplier qualification thru the process of capability matching, supplier risk assessment, supplier self-assessment, onsite qualification audit, qualification database management.
- Material (Component) Qualification---Support component engineering in their Implementation of PPAP (FAI). PPAP obtaining Material Certificates, Quality/Process Control Plan, FMEA, MSA, Process Parameter Sheet, RoHS compliance, Reliability Test, COC, etc.
- Pilot Run Tracking---Track the new qualified parts quality performance to ensure they meet the customer quality requirements in pilot run phase. Drive supplier corrective action from supplier in Pilot Runs (1-3 lots) and smoothly transfer the pilot run to mass production.
- Hot Issue Solution and Trouble Shooting--- Working as SME (Subject Matter Expert) to support on supplier quality hot issues, trouble shooting, and corrective action management.
- Support Maintenance Audit---Support the annual maintenance audit for existing suppliers with SQE. Hot Issue Solution and Trouble Shooting--- Working as SME (Subject Matter Expert) to support on supplier quality hot issue and trouble shooting.
- Support Supplier CIP (Continuous Improvement Program) --- Support supplier to use the quality tools to improve manufacturing process and product quality.
- ECO/ECN/SCR implementation---Handle with ECO/ECN/SCR from customer, follow up on the status in case that PPAP/FAI is required prior to production.
Here is some of what you'll need (required):
- Bachelor's degree (Mechanical or Biomedical a plus)
- Minimum 3 or 5-years' experience in similar position
- Medical Devices background.
- Excellent customer interfacing skills
- Knowledge of the MS Office (Excel, Power Point)
- Ability to interface and communicate with different levels of the organization
- Strong communication skills
Here are a few of our preferred experiences:
- Auditing experience
- ISO 13485 / FDA 21 CFR 820
Here are a few examples of what you'll get for the great work you provide:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
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