Staff Quality Systems Specialist (Hybrid)

Stryker • Mahwah, NJ

92d • $92,600 - $148,400 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• $92,600.00 - $148,400.00 salary plus bonus eligible + benefits.

What This Job Offers

• Job Type: Full-time
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree