Supplier Quality Engineer II
Irvine, CA
Schedule:
Standard Working Hours
Duration:
10-Month Contract
Pay:$44-49/hr (W2)
Our client is a leading organization in the medical device industry dedicated to delivering innovative, high-quality solutions that improve patient outcomes.
The Supplier Quality Engineer II will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative and life-saving medical devices. This individual will facilitate compliance with applicable internal and external requirements. You will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role works in close partnership with R&D, Operations, Quality, Sourcing, and RA.
Essential Functions and Responsibilities
- Ensure compliance with all Federal, State, local, and company regulations, policies, and procedures
- Work with suppliers to ensure quality system and supplied product requirements are understood and successfully met
- Help define supplier qualification requirements for OEM and custom materials and devices
- Ensure validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and industry best practices
- Support completion of Design Development File requirements applicable to supplied components, subassemblies, devices, and services
- Support risk management and validation activities with suppliers
- Develop inspection methods and procedures for receiving inspection and/or supplier final release
- Execute test method validation activities for receiving inspection and/or supplier final release
- Assess non-conformances and lead closure of SCARs as needed
Education / Experience
Required:
- Bachelor’s degree in Engineering or Scientific field with at least 2 years of experience in supplier quality, manufacturing, or quality engineering functions
- Experience in a highly regulated industry
Preferred:
- Engineering degree
- Experience with supplier quality engineering activities, including external supplier vendor audits
- Experience with Class II and Class III medical devices
- Medical device, pharma, biotech, or other regulated industry experience
- ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
- Six Sigma Black Belt and/or LEAN Manufacturing experience
- Domestic and international travel up to 25%
Knowledge / Skills
- Effective problem-solving techniques and experience with technical tools (e.g., Root Cause Analysis, dFMEA process, Gage R&R, etc.)
- Proficient understanding of Design Controls, test method development and validation, and risk management
- Ability to conduct effective root cause investigations; assess corrective action strategies; and evaluate effectiveness as applied to NCRs and SCARs
- Demonstrated ability to apply statistical quality engineering tools
- Ability to read and interpret drawings
- Knowledge and understanding of FDA and international regulatory standards for medical devices preferred
- Ability to manage multiple and frequently changing projects and priorities
- Ability to work independently without close supervision
- Effective communication and conflict resolution skills
- Highly developed time management, communication, and documentation skills
- Strong communication and organizational skills to effectively manage and achieve results with external suppliers
- Knowledge of NCR and CAPA elements preferred
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