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

Date Posted: 11/25/2018

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 your will lead the integration of Quality Systems for acquired sites. 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 build capabilities with local sites, with the goal that they can serve as a site process owner independently.

Lead the Integration of Quality Systems for acquired sites:

  • You will facilitate recurring meetings with subject matter experts at sites within the Medical division to identify best practices and plans to implement new processes.
  • Enhance and build 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
    • Maintain evaluations of risk thresholds.
    • Maintain the product family hazard/harm lists.
    • Drive continuous improvement to the risk management processes.
  • Support Advance Quality Engineers (as needed):
    • Quality Report
    • MAUDE database analysis
    • NC and CAPA analysis
    • Risk Management
  • You will serve as a subject matter expert for the Merger & Acquisition quality system process, including advising on Business Development projects and conducting Due Diligence of targets
  • You will manage/lead business development/due diligence activities that help us achieve our strategic vision and key initiatives. Advise on key risks and opportunities that may form input into integration planning activities.
  • You will manage integration plans to closure, which include managing a variety of tasks across multiple locations.

Regulatory Compliance:

  • You will act as a key contact in external audits on our Quality Systems and Quality Processes.
  • You will lead the representation of Quality Systems and Quality Processes which you own in External Audits.
  • You will monitor compliance to Medical Quality Procedure, FDA (and other) Quality System Regulations (QSR’s) and update as necessary

Advanced Responsibilities:

  • You will review progress with management and stakeholders, escalating any issues or gaps for resolution and direct priorities among RA/QA Heads at other sites.
  • You will often lead key initiatives or special projects that impact the division
  • You will participate in Quality System projects across multiple divisions and/or sites

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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