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Sr. Engineer, Supplier Quality - Wayne, NJ

Company: Getinge
Location: Wayne
Posted on: September 16, 2022

Job Description:

Job Overview This position will support the Supplier Quality Manager in developing initiatives for continuous improvements to Supplier Quality program in compliance with applicable domestic & international requirements laws, and guidance across the New Jersey sites. Job Responsibilities and Essential Duties Certified Lead Auditor with extensive auditing experience Lead Auditor for supplier audits at both sites (Mahwah & Fairfield) including pre and post audit related documentation and compliance. Manage the Supplier Audit Program for both sites. Ensure compliance to Getinge procedures. Execute and follow through from initiation to completion on findings from supplier audits. Manage supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews. Lead quality issues with suppliers and partner with internal customers. Lead effective supplier containment and corrections/corrective actions. Lead efforts on improvement of quality of suppliers. Drive supplier requirements and supplier performance objectives Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability across both Mahwah & Fairfield sites SME in Supplier Quality for external audits as needed. Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies. This is applicable towards both Mahwah & Fairfield sites. Experience in Corrective Action Preventive Action. Ensure compliance to Supplier Audit Schedule for both Mahwah & Fairfield sites Lead/provide support to other SQEs in the team for both Mahwah & Fairfield sites Lead multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion for both Mahwah & Fairfield sites. Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for both Mahwah & Fairfield sites Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system for both Mahwah & Fairfield sites Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers Ensure alignment/lead standardization efforts on supplier management processes across sites. Engages interest and participation of others and has a collaborative approach to working with others Proactively contributes to the team Minimum Requirements 5+ years' experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment. Must have Supplier Auditing experience. Minimum 5 years Supplier Quality Engineering experience. Certified Lead Auditor Up to 15% travel Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

Keywords: Getinge, Wayne , Sr. Engineer, Supplier Quality - Wayne, NJ, Engineering , Wayne, New Jersey

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