Job Information
Epredia Supplier Quality Engineer in Shanghai, China
Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.
People – We win as a team.
Customer – We deliver customer-centric solutions.
Continuous Learning – We learn and always aim to be better.
Innovation – We innovate every day.
Results – Results matter for all of us.
What you will do:
Manage the supplier quality program including selection and approval, supplier performance monitoring, change notifications and corrective actions.
Ensures suppliers are ready and capable to produce existing products and launch new products.
Monitor supplier performance (KPI’s) through regular communication, frequent reporting, and follow-up.
Work closely with the Purchasing Team to qualify suppliers and perform both initial and periodic follow-up assessments/audits.
Act as Lead Auditor during supplier audits. Ensure management of supplier audits from planning to completion.
Approve and monitor supplier CAPA/SCAR plans and activities to closure, including objective evidence of effectiveness.
Participate in design changes related to supplier provided materials. Coordinate the preparation of quality test/inspection plans (including design verification & validation) for proposed new components and/or existing components from a new supplier.
Qualifications & Skills:
Bachelor’s degree in engineering or technical discipline or its equivalent.
5+ experience in supplier quality assurance.
Knowledge of Magma, Flow 3D, Mold flow, etc.,
Knowledge of GD&T gauge design, methods and equipment for material, dimension, and performance testing.
Must have experience performing effective root cause analysis, corrective, and preventive actions.
Fluent written and verbal English skills are required.
Familiar with injection molding process and mold structure, understanding of plastic parts raw material characteristics, production quality development and control is preferred.
Lead auditor training required; Lead Auditor certification (CQA/ASQ/ISO) is preferred.
Lean Six Sigma Green or Black Belt certification is preferred.
Experience in working with Medical Device/IVD regulated products is preferred.
Experience and knowledge of ISO13485/ FDA 21 Part 820 requirements preferred.
Up to 50% travel.
TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.