Top Prospect Group
Overview
We are recruiting for a very specific position – Supplier Quality Engineer – to help manage and improve the overall quality of our supply chain partners, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 requirements for suppliers and supplied parts. This role is part of the Quality team and works closely with Incoming Inspection, Engineering, and Material Management. The Supplier Quality Engineer will be the primary driver of supply-based NCR disposition and closure, while also weighing in on quality, engineering, and continuous improvement throughout the product lifecycle. Key Responsibilities
Assist inspection with evaluating cosmetic specifications and intricate component requirements; request input/communication with QE/ME as needed. Interface with Incoming Inspection, review results, document dispositions, and obtain approvals for timely closure of Nonconformance Reports. Serve as a key contributor in weekly Incoming Inspection NCR MRB meetings. Collaborate with MMC Incoming Inspection and suppliers to investigate measurement discrepancies. Communicate failures to suppliers, request SCARs when necessary, and verify corrective action effectiveness. Work with Supply Chain to obtain RMA numbers and ensure dispositions are carried out per NCR approval. Generate and distribute supplier scorecards. Conduct ASL updates in PLM for new suppliers, change notifications, etc. Partner with suppliers, Manufacturing Engineers, and QEs to evaluate component issues, walk processes, and determine root causes. Support Supplier Development and Sr SQE with teleconferences, audits, and high-risk supplier investigations. Facilitate review and approval of supplier-initiated changes and communicate approvals across Quality and other teams. Identify preventive actions and continuous process improvement opportunities with suppliers. Assist with customer and regulatory audits. Recommend SOP improvements tied to QA GMP compliance. Qualifications
Bachelor’s in Engineering or related experience. 2+ years of experience in Quality Assurance, preferably in medical device manufacturing. Certified Quality Auditor/Supplier Auditor a plus. Familiarity with ISO 13485:2016 and FDA 21 CFR Part 820. Strong CAD and mechanical drawing interpretation skills. Ability to analyze data accurately and interpret results. Detail-oriented with strong verbal and written communication skills. Demonstrated ability to manage multiple tasks in cross-functional teams. Willingness to travel ~20% domestically and internationally. Be part of a fast-paced, multidisciplinary, and inventive environment where innovation and collaboration drive improvements in quality and compliance. This role requires attention to detail, adaptability, and a commitment to continuous improvement. About Us
Top Prospect Group, founded in 2010, is a technical staffing firm committed to matching top professionals with industry-leading clients. In 2023, we joined HW Staffing Solutions, expanding our reach in logistics, manufacturing, and technology sectors nationwide. Benefits
Medical insurance Vision insurance 401(k)
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We are recruiting for a very specific position – Supplier Quality Engineer – to help manage and improve the overall quality of our supply chain partners, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 requirements for suppliers and supplied parts. This role is part of the Quality team and works closely with Incoming Inspection, Engineering, and Material Management. The Supplier Quality Engineer will be the primary driver of supply-based NCR disposition and closure, while also weighing in on quality, engineering, and continuous improvement throughout the product lifecycle. Key Responsibilities
Assist inspection with evaluating cosmetic specifications and intricate component requirements; request input/communication with QE/ME as needed. Interface with Incoming Inspection, review results, document dispositions, and obtain approvals for timely closure of Nonconformance Reports. Serve as a key contributor in weekly Incoming Inspection NCR MRB meetings. Collaborate with MMC Incoming Inspection and suppliers to investigate measurement discrepancies. Communicate failures to suppliers, request SCARs when necessary, and verify corrective action effectiveness. Work with Supply Chain to obtain RMA numbers and ensure dispositions are carried out per NCR approval. Generate and distribute supplier scorecards. Conduct ASL updates in PLM for new suppliers, change notifications, etc. Partner with suppliers, Manufacturing Engineers, and QEs to evaluate component issues, walk processes, and determine root causes. Support Supplier Development and Sr SQE with teleconferences, audits, and high-risk supplier investigations. Facilitate review and approval of supplier-initiated changes and communicate approvals across Quality and other teams. Identify preventive actions and continuous process improvement opportunities with suppliers. Assist with customer and regulatory audits. Recommend SOP improvements tied to QA GMP compliance. Qualifications
Bachelor’s in Engineering or related experience. 2+ years of experience in Quality Assurance, preferably in medical device manufacturing. Certified Quality Auditor/Supplier Auditor a plus. Familiarity with ISO 13485:2016 and FDA 21 CFR Part 820. Strong CAD and mechanical drawing interpretation skills. Ability to analyze data accurately and interpret results. Detail-oriented with strong verbal and written communication skills. Demonstrated ability to manage multiple tasks in cross-functional teams. Willingness to travel ~20% domestically and internationally. Be part of a fast-paced, multidisciplinary, and inventive environment where innovation and collaboration drive improvements in quality and compliance. This role requires attention to detail, adaptability, and a commitment to continuous improvement. About Us
Top Prospect Group, founded in 2010, is a technical staffing firm committed to matching top professionals with industry-leading clients. In 2023, we joined HW Staffing Solutions, expanding our reach in logistics, manufacturing, and technology sectors nationwide. Benefits
Medical insurance Vision insurance 401(k)
#J-18808-Ljbffr