Staff Quality Systems Engineer in Portage, MI at Stryker Corporation

Date Posted: 9/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Portage, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/15/2018
  • Job ID:
    R402563

Job Description

Technical Lead / Business Architect:

  • Quickly learn and become the divisional technical lead in the Windchill 11 platform.
  • Facilicate and execute on decision making critical to the transition and implementation of new business processes as part of the Windchill work flows.
  • Work closely with the Quality System process owners to make incremental changes that will aid in the transition to the windchill processes.
  • Conduct meetings with all process owners and SMEs to extract process information and to facilitate data cleansing decisions.
  • Support the SGS and IS partners in data transformation and process change implementation
  • Act as a key training developer for both content and train the trainer training.

Quality Systems Engineering / Project Management:

  • Identify opportunities for enhancement of existing quality and regulatory systems/tools in support of our departmental and divisional visions. 
  • Lead quality support as a consultant to our organization to build understanding of quality concepts and drive our quality culture.
  • Schedule and organize meetings with key stakeholders, process owners, managers, and SMEs on a regular basis.
  • Ability to help influence the business with the adoption of the new processes.
  • Report feedback and project/process updates on a regular basis
  • Create and maintain project plans that meets the overall project goals
  • Manage SMEs to help drive project engagement
  •  May own or support validation and CSV activities and act as the Divisional Process Owner.

Regulatory Compliance:

  • Ensure our compliance to Medical Quality Procedures and FDA Quality System Regulations (QSR’s)
  • Ensure the Change Control processes meet all compliance requirements (ex: Write it Right!)

Advanced Responsibilities:

  • Often has latitude for un-reviewed action or decisions
  • Regularly works with minimum supervision, conferring with superior on unusual matters
  • Viewed as a department/divisional resource in the area of expertise

Qualifications:

  • BS or MS in Engineering

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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