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Sr. Quality Assurance Engineer - 16274

Company: Impact Business Group Inc
Location: Kalamazoo
Posted on: January 7, 2021

Job Description:

Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. Quality Assurance Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.



Position Description (Principle Duties and Responsibilities)



Work closely with operations and the business functions to ensure quality performance of product and processes.
Collaborates with Divisional QA, cross-functional and suppliers teams to address top quality issues.
Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise.
Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
Disposition non-conforming product within MRB, issuing NC's as appropriate.
Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
Engage in the development and improvement of the internal manufacturing processes for existing products.
Performs critical assessment of internal and supplier proposed change management activities.
Performs PPAP activities for supplier changes
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Support execution and analysis of manufacturing related complaints and product field actions.
Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
Support the creation and maintenance of inspection methods and sampling.
Applies statistical methods of analysis and process control to current operations.
Engage and interface in internal and external audits providing subject matter expertise Support the development and review of process and equipment validation/qualification and MSA of internal processes.
Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier initiated changes.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.



Requirements



Bachelor's in mechanical/Electrical/Biomedical Engineering Required
Must possess excellent presentation and communication skills.
5+ years' experience with completing part qualifications (PPAPs)
5-7 + years' experience in Global Enterprise with Sr Quality / Quality Engineering roles and experience.

Keywords: Impact Business Group Inc, Kalamazoo , Sr. Quality Assurance Engineer - 16274, Engineering , Kalamazoo, Michigan

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