Sr. Quality Engineer (2nd Shift) - 30397BR - EN in Salt Lake City, UT at Stryker Corporation

Date Posted: 5/12/2018

Job Snapshot

Job Description

Stryker Neurovascular is committed to Complete Stroke Care through innovative products, technologies and services for ischemic and hemorrhagic stroke. By advancing the practice of less-invasive medicine, providing healthcare professionals more endovascular solutions and promoting clinical education and support, Stryker Neurovascular is dedicated to helping deliver better patient outcomes.
This role will support the Mixed Model Packaging Line.
You will provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes.
You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards.
You will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

  • Working closely with operations and the business functions to ensure quality performance of product and processes.
  • Manage oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
  • Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
  • Analysis and review of concession requests.
  • Review and approval of change management activities.
  • Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
  • Support execution and analysis of QATs.
  • Be an advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
  • Be proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
  • Be proficient in and make continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
  • Be proficient in statistical methods and application.
  • Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • Assist in the development, responsible for review & approval of process and equipment validation/qualification.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Be responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor others in quality topics and activities.

Job Requirements

BASIC QUALIFICATIONS:

Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality discipline, OR
Masters of Science, Engineering or related subject with 0 or more years of experience in a quality discipline.

PREFERRED QUALIFICATIONS:
  • Previous experience in a regulated environment is preferred.
  • CQE or equivalent course work / experience is preferred.
  • Proficient in understanding of Med Device manufacturing processes preferred.
  • Familiarity with ISO 13485, GDP, GMP preferred.
  • Lean Six Sigma training is highly preferred

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