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Becton Dickinson and Company is looking for a Sr. Supplier Quality Engineer to perform the following duties:

• Measures supplier performance based on defined metrics; will need to gather information from cross functional teams to ensure performance targets are maintained.
• Leads the Supplier Management Committee (SMC) meeting at UCC business unit to manage suppliers.
• Interfaces with Integrated Supply Chain, Operations at multiple manufacturing sites, Design Quality, and RandD to execute supply chain improvement projects.
• Under the direction of the Corp Supplier Quality, contributes to the development of supplier QA contracts for critical suppliers to ensure quality, delivery, capacity and manage change control.
• Crafts, reviews and approves component validations, process capability analysis, supplier change request (SCRs), and internal BD product specifications, where applicable.
• Creates, reviews, and approves Protocols, Process and Product Validations, reviews and approves Risk Assessments such as FMEA, FMECA or FTA in conjunction with suppliers.
• Builds, reviews and approves Quality System Documents (CAPA, Audits, SCRs, SCARs)
• Supports supplier relationship management for Urology and Critical Care (UCC).
• Collaborate with manufacturing facility or other Division Facilities and Franchise teams on key projects assigned.
• Assists with defining appropriate metrics/measurements for ongoing supplier analysis.
• Reviews QA, ISO and other audit reports for suppliers subject to FDA regulations to assist with identification of risks and opportunities.
• Performs internal and external Supplier Quality System audits and qualification audits as part of supplier assessment and development. Must maintain internal lead auditor qualification.
• Analyzes process and product non-conformances and complaint trends related to supplier issues, and implement comprehensive corrective and preventive action plans via issuing and ensure that comprehensive Supplier Corrective Action Requests (SCARs) plans are developed by suppliers when non-conformances or performance issues indicate need.
• Mentors others in supplier performance management.

Hybrid in-office/remote position

This position requires aMasters degree in Science (any), Engineering (any), Technology (any), Biology or related field of study AND Two (2) years of experience in the job offered or related occupation in which the experience was gained. In lieu of a Masters degree in Science (any), Engineering (any), Technology (any), Biology or related field of study AND Two (2) years of experience in the job offered or related occupation in which the experience was gained, the employer will also accept a Bachelors degree in Science (any), Engineering (any), Technology (any), Biology or related field of study AND Five (5) years of experience in the job offered or related occupation in which the experience was gained. Must have demonstrated experience with:

Applicants must also have demonstrated experience with:

• FDA (medical device, food, or pharmaceutical) regulated environment in any technical role;
• FDA QSR or ISO 13485 compliance;
• Supplier Quality Engineering in a regulated environment (Medical device, pharmaceutical, defense, aerospace, automotive or similar industry);
• 21 CFR Part 820 and 21 CFR Part 803;
• Conducting post-market quality audits; and
• CAPA or SCARs - evaluating suppliers on non-conformances.