Senior Quality Systems Specialist (Hybrid)

Work Flexibility: Hybrid

Stryker is seeking a Senior Quality Systems Specialist for our Joint Replacement division. This is a hybrid position based in Mahwah, NJ or Weston, FL.

 

As the Senior Quality Systems Specialist, you will support and enhance our Change Management system, ensuring alignment with global regulatory standards and driving continuous improvement across the Quality Management System (QMS).

 

What you will do

• Manage and improve the Change Management/Change Control process to meet regulatory and business needs

• Ensure QMS compliance with FDA, ISO, MDD, and other global regulatory requirements

• Support internal and external audits, Management Reviews, and Quality Planning activities

• Identify and implement process improvements using data-driven insights and metrics

• Collaborate cross-functionally to align QMS with business operations and new product development

• Develop and deliver training on Change Management processes and best practices

• Maintain and update QMS documentation to reflect current practices and regulatory expectations

• Contribute to system integration and IS support for QMS-related processes

What you need

Required

• Bachelor’s degree in Science, Engineering, Business, or a related discipline

• Minimum 3 years of experience in a manufacturing environment or equivalent

• Experience in a regulated environment with direct interaction with regulatory agencies

Preferred

• Thorough knowledge and understanding of US and International Medical Device Regulations.

• Strong knowledge of Quality Systems (CAPA, change control, audits, Management Review, Quality Planning, etc.)

$69,100.00 - $128,900.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

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.