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DATE ADDED: Thu 11/10/2018

Quality Engineer

Parsippany, USA


Job Description

Title: Quality Engineer (Temporary)

Department: Operations and Quality

Travel: Limited

* Find solutions to our patients’ unmet clinical needs and advocate for their cause

* Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently

* Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance

* Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth

* Deliver value to our customers and shareholders

Job Summary

The Quality Engineer is responsible for driving compliance within supply chain. This includes quality oversight of Product Development/Design Control activities (DHF), production documents (DMR), engineering/process changes (ECN), and, as needed, support of other quality/compliance activities (e.g. – NCRs, complaints, CAPA, etc.). In addition, this role will support Product Development and Operations in supplier selection, supplier-related risk assessment, and development of process standards/documentation.


* Represent Quality Assurance on Design Control projects ensuring compliance with procedures, QMS standard/regulation requirements, applicable product standards, and good documentation practices

* Review and approve Design History File documentation including Design Plans, Input/Output (Traceability) Matrices, Risk Management Files, Verification/Validation Protocols, Design Transfer Checklists, and other required documents/protocols

* Ensure manufacturability, testing, and inspection requirements are met by reviewing supplier qualification, validation, risk management, process, and inspection documentation for compliance

* Support the Engineering Change Notice (ECN) process and assess, review, and/or approve product, process, and supplier changes for adequacy, compliance, and comprehensiveness

* As needed, assist in the investigation of product complaints, non-conformances, and CAPAs


* BS or higher in Engineering, Science, or other related discipline

* 4+ years of medical device experience in a Quality or Operations role

* 2+ years working experience with IS0 13485 and/or 21 CFR Part 820

* Fundamental understanding of Design Control and change management processes

* Familiar with best practices for sample size selection, design verification/validation, process validation/control, and change management

* Able to work independently and on cross-functional project teams

* Demonstrate a high level of professionalism at all times

* Effective at building relationships inside and outside the company

* Able to communicate both orally and in written form to multiple levels of the company


Company Description
Russell Tobin, one of the nation’s leading professional recruitment and staffing advisory firms, offers a tailored approach to helping organizations connect with direct hire and contract employees across a variety of skill-sets and industries. Having a depth and breadth of industry expertise, our talent advisers and recruitment specialists are able to provide customized and swift solutions to fulfill client and candidate hiring needs. We work with each and every candidate to assess their respective goals and subsequently build a comprehensive and transparent road-map for achieving a successful placement. We take great pride in cultivating an open and honest relationship with our clients and candidates in an effort to create a long-term relationship.Our dedication to results, along with our reputation built on a consistent and successful track record of placing candidates, enables us to continuously provide best-in-class services. Russell Tobin is a division of Pride Global, a minority-owned integrated human capital solutions firm headquartered in New York with operating companies throughout the United States, Canada, India and Brazil. Pride Global companies focus on a diverse array of services including vendor management, payroll programs, business process optimization, and staffing for both direct hire and contingent labor. Follow Russell Tobin on Facebook: # Russell Tobin on Instagram: @russelltobin

Role: Quality Engineer
Job Type:
Location: Parsippany,

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