Supplier Quality Engineer II - Fairfield, NJ in Fairfield, NJ at Getinge

Date Posted: 10/8/2019

Job Snapshot

  • Employee Type:
  • Location:
    Fairfield, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job Purpose

The Supplier Quality Engineer (SQE) is responsible for ensuring the Datascope supply chain provides components, assemblies, and products that meet expected quality levels. The SQE works cross functionally with Operations, Engineering, and Quality Organizations, to continuously improve supplier performance by implementing process controls and develop quality assurance plans.

Job Functions:

  • Manage supplier quality performance and measurement KPls 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.
  • Participate in the Production Part Approval Process (PAPP).
  • Support implementation of supplier process validation.
  • Review and improve the quality of suppliers.
  • Define supplier objectives and design requirements.
  • Drive supplier requirements and supplier performance objectives
  • Develop commodity strategies.
  • Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability.
  • Engage in external and internal audits as needed. Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies.
  • Perform the role of a Supplier Corrective Action Request Coordinator
  • Lead Supplier Audit Program for both Mahwah & Fairfield sites
  • Lead/provide support to other SQEs in the team for both Mahwah & Fairfield sites
  • Support the Supplier Quality Manager responsible for delivering all aspects of the Supplier Quality Assurance function for both Mahwah & Fairfield sites
  • Work on multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion
  • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for both Mahwah & Fairfield sites
  • Report on Key Performance Indicators (KPls) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system
  • Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers

Required Knowledge, Skills and Abilities:

Knowledge of the principles and practices of process validation.

A working knowledge of quality improvement tools and techniques.

Knowledge of auditing procedures.

Work related travel (Domestic and overseas) 10 — 25 %

Minimum Requirements:

A Bachelor degree (or equivalent) in Engineering, Science or related field is requried, plus 5+ years' experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment.

Preferred Supplier Auditing Experience.

Minimum 5 years Supplier Quality Engineering experience.

Getinge Group 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.