Quality Assurance / Regulatory
Getinge

Job Info

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Job Purpose

The Supplier Quality Engineer (SQE) is responsible for ensuring the 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, track and expedite First Articles and Validation activity of business critical, and process change events.

*Perform supplier process validation review. Manage supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers

*Coordinate specification review for changes, clarification, harmonization; initiate, review and approve change notices

*Support cost savings, consolidation and transfer programs; Participate in projects and continuous improvement initiatives as assigned. Complete NCMR's related to incoming components and assist SCAR resolution.

*Modify/update CAD files. Coordinate and manage first article production runs. Participate in the Production Part Approval Process (PAPP).

*Lead quality issues with suppliers and partner with internal customers. Lead effective supplier containment and corrections/corrective actions.

*Supplier Development - establish & sustain effective partnerships with suppliers, develop technical capability. Perform the role of a Supplier Corrective Action Request Coordinator; Support Supplier Audit Program for Wayne, Mahwah & Fairfield sites

*Engage in external and internal audits as needed. Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies.

*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 Wayne, 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

Required Knowledge, Skills and Abilities:

* Bachelor's degree in Engineering or equivalent. 3+ years' experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment. Minimum 2 years Supplier Quality Engineering experience.

*Preferred Supplier Auditing Experience.

*Must have strong verbal and written communication skills. Ability to exercise sound judgment, be well organized, take initiative, be flexible and must work well under pressure, work effectively with both employee and management and be able to facilitate resolution of complex issues. Ability to apply sound procurement practices and principles and provide solutions to procurement and purchasing issues.

*Previous working knowledge of MRP or equivalent system is required. Prior SAP experience is preferred; Familiarity with engineering drawings and basic experience working with CAD systems.

*Statistic knowledge working with sampling plan and process validation and Knowledge of auditing procedures.

*Work related travel (Domestic and overseas) 10-15%

We look forward to receiving your application.

This job has expired.