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Staff Quality Systems Specialist (Hybrid)

Staff Quality Systems Specialist (Hybrid)

StrykerMahwah, NJ, US
3 hours ago
Job type
  • Full-time
Job description

Staff Quality Systems Specialist, (Hybrid)

Stryker is hiring a Staff Quality Systems Specialist, (Hybrid) to join the team in Mahwah, NJ. This is a hybrid role, and candidates must live within a reasonable commuting distance to the site. The role is highly visible and requires strong engagement across leadership, HQ, and cross-functional teams.

What You Will Do

  • Ensure QMS compliance with internal and external regulatory requirements (FDA, ISO, MDD, country-specific).
  • Develop and implement future-state QMS strategies aligned with business needs.
  • Identify and drive improvements through the quality planning process.
  • Lead development and modification of QMS processes and documentation.
  • Act as a subject matter expert during internal and external audits.
  • Plan and support external audit activities, including execution and follow-up.
  • Manage a Management Review and Quality Planning Review forum.
  • Assess and implement structural improvements to optimize QMS efficiency.
  • Benchmark best-in-class practices and ensure alignment with regulatory expectations.
  • Liaise with notified bodies to manage certification changes.
  • Coordinate QMS activities to support project milestones and NPD requirements.
  • Lead QMS strategy execution and improvement initiatives.
  • Represent QMS expertise during audits and IS system change assessments.

What You Need

  • Bachelor's degree in science, engineering, business, or related discipline.
  • Minimum of 5 years of experience in a manufacturing environment or equivalent.
  • Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.).
  • Experience in a regulated environment and interaction with regulatory agencies.
  • Experience performing and managing external audits by Notified Bodies, Regulators, or other Agencies / Accreditors.
  • Thorough knowledge and understanding of US and international medical device regulations.

    • Preferred

  • Experience in compliance risk situations.
  • Strong knowledge of system integration and IS system support requirements.
  • Strong communication, project management, and influencing skills.
  • Ability to plan, organize, and implement multiple concurrent tasks.
  • Strong interpersonal, written, oral communication, and negotiation skills.
  • Analytical and problem-solving capabilities with the ability to draw insights from data and define executable actions.
  • Demonstrated ability to work in cross-functional team environments.

    • Salary : $92,600.00 - $148,400.00 plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

    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.

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    Quality System Specialist • Mahwah, NJ, US