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Engineer II, Supplier Quality - Wayne, NJ

Maquet Cardiovascular LLC
Wayne, NJ Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/21/2025

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview :

This position is responsible for ensuring the Getinge supply chain provides components, assemblies, and products that meet expected quality levels. 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. This position will work cross functionally with Operations, Engineering, Sourcing / Purchasing and Quality Assurance Organizations, to develop and implement Supplier Quality programs and procedures that aligns to the corporate guidelines.

Job Responsibilities and Essential Duties

  • Oversee processes as a process owner and harmonization of Supplier Quality related processes such as Supplier Management, Supplier-Initiated Changes, SCARs, Getinge Part Approval (GPA), Supplier Audits, etc.
  • Serve as Supplier Quality Lead / SME during internal audits and 3rd party inspections / audits (FDA, BSI, TUV). Oversee audit / assessment of current and potential new suppliers
  • Responsible for driving failure analysis and reports on effective corrective actions / supplier corrective action requests (SCARs), NCMR’s and supplier related CAPA’s.
  • Manage supplier quality performance results and measurement KPIs. Enable reporting of metrics for monthly management meetings and management reviews.
  • Initiate & Support Supplier Development activities - establish & sustain effective partnerships with suppliers, resolve systemic supplier issues, and develop technical capability.
  • Participate in the Part Qualification process. Negotiate and Finalize Quality Agreements such as Supplier Quality Agreement, Service Agreement, Intra-Company Quality Agreement, etc. for supply base spread globally
  • Oversees validations and qualifications of supplier facility to qualify manufacturing processes and overall quality of part / component manufacturing.

Minimum Requirements

  • Bachelor’s degree in Engineering.
  • Previous experience in Supplier Quality Engineering and supplier auditing preferred
  • 4 years’ experience in a medical device (capital goods with electromechanical components and / or disposables) manufacturing environment.
  • Salary Range : $89k - $105k

    LI-LG1

    About us

    With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

    Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

    Salary : $89,000 - $105,000

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