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Quality Engineer

Global Medical Device Manufacturing Company Kalamazoo, MI

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Overview

  • Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
  • Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates.
  • Analyzes reports and defective products to determine trends and recommend corrective actions.
  • Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.
  • This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
  • Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
  • Job requires an understanding and application of procedures and concepts of own discipline. 
  • The job requires the ability to make judgements based on practice and previous experience. 
  • This job typically requires a degree or equivalent and no experience.

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.
  • Own or support identified internal CAPAs abnd manage to timely root cause investigation, implementation and closure.
  • Disposition non-conforming product within MRB, issuing NC's as appropriate.
  • Communicate 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.
  • Participates 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.
  • Advocate of 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.

 

Company Description
Company is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Offering a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neuro-technology & spine products to help people lead more active and more satisfying lives.

Global Medical Device Manufacturing Company

Why Work Here?
Company offers Meaningful innovation, Growth and Opportunity. It's most Admired Company in Medical Products and Equipment since 2005

Company is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Offering a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neuro-technology & spine products to help people lead more active and more satisfying lives.

Global Medical Device Manufacturing Company's Logo

Address

6201 South Sprinkle Rd

Kalamazoo, MI
49001 USA

Industry

Manufacturing

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