Position Title: Supplier Quality Engineer II Work Location: Irvine, CA, 92614 Assignment Duration: 10+ months Work Arrangement: Onsite Position Summary: 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 to applicable internal and external requirements. Background & Context: 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. Key Responsibilities: • 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. Qualification & Experience: • Bachelor’s degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions • Highly regulated industry experience • Engineering degree • 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) Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 45.00/hr.