Staff Engineer, Quality in Salt Lake City, UT at Stryker Corporation

Date Posted: 10/25/2018

Job Snapshot

Job Description

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.  

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!”

What You Will Do

  • Deliver high quality products and processes that contribute to Stryker’s highly effective quality system. 
  • Provide quality leadership and direction in quality assurance, control and preventive activities within operations.
  • Advocate and lead the execution of initiatives & projects to enhance quality performance.
  • Mentor and provide technical direction across multiple areas of expertise.
  • Ensure compliance to regulation and standards.
  • Mentors, provides oversight and approval of NC & CAPA, activities and high level expertise in problem solving and root cause activities.
  • Initiate and lead in the development and improvement of the manufacturing processes for existing and new products.
  • Oversight of and leads investigations during concession management.
  • Review and approval of change management activities, challenges change effectiveness and drives strong review.
  • Interpret KPI trends, take action as necessary, driving a continuous improvement process.
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
  • Be a subject matter expert in risk management practices and tools, having high expertise in process risk.
  • High proficiency in statistical methods and application.
  • Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.
  • Aids in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, management and support of ship, product Holds, potential product escapes.

    Who We Want

    A Quality Engineer with the ability to drive quality and deliver results.  Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.

    • CQE or equivalent course work / experience preferred.
    • Proficient in understanding of Med Device manufacturing processes preferred.
    • Proficient in ISO 13485, GDP, GMP.
    • Lean Six Sigma training a distinct advantage.
    • Excellent communication skills and attention to detail.
    • Have a good understanding of engineering and quality practices & methods.
    • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
    • Exhibits strong leadership and mentoring behaviours.
    • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
    • Must be willing to work as part of a multi-site team, with some travel required.
    • High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
    • Highly developed problem solving and strong analytical skills.
    • Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
    • Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
    • Presents as a change agent and adopts a continuous improvement orientation to the role.
    • Ability to be the voice of Quality when dealing cross functionally, will take the lead discussions / meetings to ensure the correct outcome.

    What you need

    • Bachelor of Science, Engineering or related subject with 4 or more years of experience in a quality discipline, or
    • Masters of Science, Engineering or related subject with 2 or more years of experience in a quality discipline
    • Previous experience in a regulated environment required.

    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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