Supplier Quality Engineer

Position:
Supplier Quality Engineer II, Req# 15816-1
Location:
Irvine, CA (100% onsite)
Duration: 10+ months contract with high possibilities of extension/conversion
Job Description:

The Supplier Quality Engineer II will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & 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 will work in close partnership with R&D, Operations, Quality, Sourcing, and RA.

• Bachelor’s degree in Engineering or a scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions
• Highly regulated industry experience
• Experience with supplier quality engineering activities, including external supplier vendor audits
• Effective problem-solving techniques and experience with technical tools (i.e. Root Cause Analysis, dFMEA process, Gage R&R, etc.)
• Proficient understanding of Design Controls, test method development & validation, and risk management.
• Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
• Experience with class II and class III medical devices
• Medical device, pharma, biotech or other regulated industry experience
• 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 is 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 get results with external suppliers
• Six Sigma Black Belt/LEAN Manufacturing experience
• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
• Domestic and international travel up to 25% (post-COVID)

• Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Works with suppliers to ensure quality system and supplied product requirements are understood and successfully met.
• Responsible for helping define supplier qualification requirements for OEM and custom materials and devices.
• Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and Industry best practices.
• Supports completion of Design Development File requirements applicable to supplied components, subassemblies, devices, and services.
• Supports risk management and validation activities with suppliers.
• Develops inspection methods and procedures for receiving inspection and/or supplier final release.
• Executes test method validation activities for receiving inspection and/or supplier final release.
• Knowledge of NCR & CAPA elements is preferred.
• Assesses non-conformances and leads closure of SCARs as needed.