Senior Quality Engineer

Stryker – Cary, IL

Who we want

Individual Contributor Roles

  • Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • What you will do

    We are a leading developer of products used to prevent hospital-acquired conditions such as ventilator-associated conditions, skin injury due to incontinence, pressure injuries, surgical site infections and healthcare worker injury across the continuum of care. From the acute care setting to the skilled nursing and long-term care setting, as well as continued care at home, we create products that make care giving easier and provide clinical outcomes. Our success is supported by a unique culture that is summed up in the phrase, keep it personal. Its our way of reinforcing a focus and commitment to our employees and customers through integrity, honesty and passion.

    As a Senior Quality Engineer, you will be a key member of the Quality Operations team ensuring the safety, efficacy, and compliance with industry practices. Working closely with Operations, Planning, Marketing, Advanced Operations, and Regulatory Affairs team members building strong relationships by fostering open communication, respect, and trust. This role is in a fast paced, high volume environment with opportunity for growth and leadership development.

    Responsibilities:

  • 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.
  • Performs PPAP activities for supplier changes
  • Design and/or implement standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of products.
  • Develop and execute standard processes, product protocols, and author technical documents including test protocols, reports and engineering studies.
  • Provide statistical rationale for sample size analysis of test data.
  • Analyze, design, and/or improve standard manufacturing procedures.
  • Root Cause investigations following 4D methodology and determining effective Corrective / Preventative Actions.
  • What you need

  • Bachelor s Degree in Engineering, Science, Quality or equivalent discipline is required.
  • ASQ Certified Quality Engineer or similar certification preferred.
  • 3+ years experience in a Quality position.
  • Proficient understanding of Pharmaceutical / Medical Device manufacturing processes, FDA CFR 210, 211, and 820, ISO 13485, ICH Q7/Q10.
  • Lean Six Sigma/Investigation (CAPA) training.
  • 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 contractors legal duty to furnish information.

    All Jobs in Cary, IL

    • Senior Validation Engineer

      Stryker Cary, IL

      View Job
    • Sr Validation Engineer

      Compest Solutions Inc Mettawa, IL

      View Job
    • Quality Engineer

      HYDAC Glendale Heights, IL

      View Job
    • Senior Validation Specialist

      Pfizer Inc. Lake Forest, IL

      View Job
    • Senior Validation Specialist

      Pfizer Lake Forest, IL

      View Job
    • VDC Engineer

      Leopardo Companies, Inc. Hoffman Estates, IL

      View Job
    • Mechanical Senior Technician - Highland Park Hospital-POM

      Aramark Highland Park, IL

      View Job
    • Sr. Engineer Mechanical Engineering-Medical Device Engineering

      Baxter International Round Lake, IL

      View Job
    • Sr. Engineer Mechanical Engineering-Medical Device Engineering

      Baxter International Round Lake, IL

      View Job
    • Sr. Engineer Mechanical Engineering-Medical Device Engineering

      Baxter International Round Lake, IL

      View Job
    • Sr. Engineer Mechanical Engineering-Medical Device Engineering

      Baxter International Round Lake, IL

      View Job

    Featured Articles

    Top 20 Highest Paying Jobs in USA

    27 August 2018

    When choosing a career it is important to look for an employment that is not only meaningful and would allow for a balance in your life but also ensures financial security alo

    read more..

    New 36 (24+12) Month STEM OPT Extension Proposed Rule [Updated]

    30 December 2015

    There has been a lot of fuss over this new extension policy that was to take place supposedly increasing the extension period for the STEM students under OPT rule. The actual rule was formally published to the federal register for the comment period. From the points t

    read more..

    SAP QM Online Training Convering Latest Course

    28 April 2016

    SAP Quality Management (QM) is another important module of SAP. It controls the products quality. It is an integrated module of SAP ERP. It is an important part of the SAP system as it is involved in catering materials management, plant maintenance and production planning. It ensures that products m

    read more..

    SAP IS Retail Online Training Course For Professionals

    02 May 2016

    Taking up the Retail Online Training under the SAP's course is very beneficial for industrial progress. SAP IS Retail is the Sap’s module that professionals prefer to use as it helps in handling of real-life challenges in the retail sector. It is superior industry-specific suite/application softwa

    read more..

    Thanks For Your Feedback

    Attach A Resume First