Senior Quality Systems Specialist (Hybrid)
Senior Quality Systems Specialist (Hybrid)
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1 Vacancy
Job Description
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
Bachelors 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.)
$69100.00 - $128900.00 USD Annual salary plus bonus eligible benefits. Actual minimum and maximum may vary based on 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 contractors legal duty to furnish information.Required Experience:
Senior IC
Employment Type
Full-Time
