Principal Supplier Quality Engineer
On-siteQuality, Georgia, United States
Job Summary
Evaluate supplier manufacturing processes using problem-solving methodologies to identify, prioritize, and resolve quality and downtime issues through detailed work-station reviews. Facilitate Design of Experiments, test method reviews, and validations at vendors while remediating material controls and traceability. Mentor local SQE teams on problem-solving techniques and collaborate with corporate and regional organizations to develop, review, and implement quality policies and procedures. Champion 100% compliance to company policies and SOPs, advising management on potential improvements to quality systems. Track and present verification of effectiveness results to cross-functional teams, influencing global quality, operations, R&D, and sourcing functions. Requires bilingual fluency in Mandarin and English, a BS degree in engineering with 6+ years of experience in medical device or regulated industries, and 20% domestic and international travel.
Required Qualifications
- Bilingual, fluency in Mandarin and English
- BS degree in engineering or related technical field
- 6+ years of relevant experience
- Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry
- Manufacturing/Manufacturing Quality experience
- Experience remediating manufacturing process and traceability controls
- Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing
- Relationship building: ability to collaborate and build strong relationships with suppliers
- Experience in process validation, design controls, risk management, and CAPA
- Ability to work independently; organized and self-driven
- Articulate communicator; adept at packaging and appropriately scaling information to the intended audience
- Ability to rapidly learn and use new software applications (e.g., PLM, ERP)
- Domestic and international travel up to 20%
Desired Qualifications
- 10+ years of medical device engineering experience preferred
- Extensive Injection Molding/Plastics experience
- Lead auditor of quality systems experience (ISO 13485 or similar)
- ASQ certification (CQE, CBA, SSGB, SSBB), or equivalent certification, strongly desired
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