Job Description

Work Flexibility: Hybrid

What you will do-

  • Supports 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).
  • Develop and execute end-to-end change management plans aligned to OnePLM (CAI, CAII and CAIII) and engage in the development of optimum future state of QMS for business needs.
  • Identify improvements and inputs into the quality planning process; execute development and/or modification of Stryker's QMS and support Management Review and Quality Planning Review and related forums, GMP and GDP within Quality organization.
  • Assess and quantify requirements for QMS requirements to optimize structure.
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements and notified body communication; internal and external quality system audits; change control assessment and approval.
  • Ensure QMS reflects actual activities, business needs and supports NPD requirement.
  • Basic project management understanding and system integration.
  • Key contributor to QMS business process(es) and support requirements.

    • What you will Need-

    Required:

  • BS in a science, engineering, business or related discipline.
  • Experience - 2 years - 5 years in manufacturing environment or equivalent.

    • Preferred:

  • Knowledge and understanding of US and International Medical Device Regulations.
  • Advanced proficiency in Excel (pivot tables, complex formulas, data analysis) and Power BI (dashboards, reporting)
  • Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.); communication and project management skills.
  • Strong interpersonal skills, written, oral communication and negotiations skills; Basic analytical and problem-solving capabilities.
  • Demonstrated ability to work in cross-functional team environments.
  • Some travel may be required.
    • Travel Percentage: None

    Apply for this Position

    Ready to join ? Click the button below to submit your application.

    Submit Application