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.
$ 92,600.00 - 148,400.00 salary 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.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.