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Sr. Staff Quality Systems Engineer in Portage, MI at Stryker Corporation

Date Posted: 1/25/2019

Job Snapshot

Job Description

Who we want

  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Senior Staff Quality Systems Engineer you will join the integration team in leading the implementation of Product Lifecycle Risk Management within the Medical Division.  You will serve as quality support and subject matter expert for our organization to build understanding of quality concepts and drive our quality culture across newly acquired sites.

  • You will serve as a subject matter expert for Mergers & Acquisitions focusing on the integration of risk management within the quality system.
  • You will advise on Due Diligence projects for future potential sites and advise on key risks and opportunities that may form input into integration planning activities.
  • Lead the development of local site capabilities in the following areas:
    • Conduct risk analysis
    • Support the risk management board process
    • Management of risk files in the entire product life cycle process
    • Maintenance of evaluations of risk thresholds.
    • Maintenance of the product family hazard/harm lists.
    • Drive continuous improvement to the risk management processes.
  • You will lead the representation of Quality Systems and Quality Processes which you own
  • You will monitor compliance to Medical Quality Procedures, FDA (and other) Quality System Regulations (QSR’s) and update as necessary

What you need

  • Bachelor of Engineering or Equivalent
  • 7+ Years
  • Regulated industry experience, medical device preferred

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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