Manager, Quality Management Systems in Mahwah, NJ at Stryker Corporation

Date Posted: 12/3/2019

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Manager, Quality Management Systems to join our Corporate Regulatory Affairs and Quality Assurance organization to be based in either Portage, MI, Allendale, NJ, Mahwah, NJ, San Jose, CA, Fremont, CA, Redmond, WA, Plymouth, MN, Leesburg, VA or Tempe, AZ.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • 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. 
  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
  • Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

What you will do

As the Manager, Quality Management Systems, you will serve as Global Process Owner, working across the Stryker landscape to identify and implement improvements to Stryker’s Global QMS.

  • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
  • Ensure optimum state of QMS for current and future business needs.
  • Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
  • Assess and quantify requirements for QMS requirements to optimize structure.
  • Ensure GMP and GDP compliance within Quality organization. Monitor changes in regulatory requirements.
  • Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Liaise with global and corporate partners to provide best-in-class global solutions and input into processes.
  • Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.
  • Lead top-priority quality-system related outputs of Global strategic planning into program or project proposals that may be implemented by one or more Global Process Owners and form them into short and long-term deliverables.
  • Negotiates the best path forward based on available time, resources and the voice of the customer
  • Explores creative options within Stryker and external to Stryker as well
  • Builds strong relationships with local QMS leaders in order to identify improvement opportunities for the Global QMS as it is implemented at a local level, then takes the initiative to develop and propose an improvement approach
  • Viewed as a global resource for QMS expertise and strategy
  • Takes initiative and responsibility to plan, coordinate and complete complex projects
  • Serve as a Global Process Owner, for Global Quality System Processes (Future State QMS Mapping and Maturity Modeling) by:
    • Coordinate division and adjacent GPO input and represent collective needs.
    • Own global documents and training materials.
    • Update Global Governance, RA/QA Leadership and PMO on direction and progress.
    • Ensure global initiatives are communicated and understood by stakeholders.
    • Serve as the voice of the process area for Stryker.
    • Travel to and leads hub and spoke meetings.
    • Lead meetings, surveys, information-gathering and global decisions for geographically dispersed teams.
    • Deliver against agreed project deadlines and reconciles implemented sites.
    • Communicate to leadership and stakeholders at a global level.
    • Lead global cultural change.

What you need

  • A Bachelor’s Degree in a Science, Engineering, Business (or equivalent discipline) required.
  • A minimum of 9 years of experience in a regulated environments/regulatory agency interactions required.
  • Experience serving in a leadership capacity for quality system activities required.
  • Experience leading cross-site/cross-division projects required.

Work From Home: Occasional

Travel Percentage: 20%

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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