Sr. Quality Engineer in Salt Lake City, UT at Stryker Corporation

Date Posted: 8/27/2018

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.

The Salt Lake City Stryker manufacturing site is experiencing phenomenal growth.  We pride ourselves on our new state of the art facility where we create amazing medical device products. We also have a nationally renowned “hands-on” medical device physician training center. 

We invite you to join our diverse workforce where you can take advantage of flexible work arrangements, outstanding benefits, ping pong table, spectacular mountain views, and our employee fitness center—we even have a climbing wall!  And this is all within a short drive from the airport or downtown!

We create multiple products that treat stroke patients and these state-of-the art devices save lives.  You will work with people here who value integrity, accountability, performance & people.  

What You Will Do

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.

What You Need

  • 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.

What Would Be Great

  • 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

Why Stryker?  “It’s the people.” That’s the answer you’ll hear most often when you ask our employees why they love working here. Come join our team in Utah at Stryker!

Apply now!

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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