Work Flexibility: Hybrid or Onsite
Senior Specialist Change ManagementStryker is seeking a Senior Change Specialist to join our Quality Management Systems (QMS) team, based in Arlington, TN. In this role, you'll focus on quality activities that uphold our commitment to excellence and compliance across our Arlington, Bloomington, and Franklin locations. You'll be responsible for initiating changes, assessing their impact, and coordinating all related tasks with meticulous attention to detail, ensuring accuracy and effectiveness across these sites.
Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working multiple days onsite.
What you will do:- Execute and/or Participate in the Change Control review forums and in multi-site forums
- Lead, facilitate, and mentor teams through all stages of the change control process
- Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes
- Liaise with Change Requester and SMEs during all stages of the Change Control process
- Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight
- Participate in cross-plant and corporate project teams in areas of change control, also support in training needs related to the change control process
- Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums
- Support in the preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits
What you need:Required- Bachelor degree in Science, Engineering or related field
- 2+ years of experience in Quality Management Systems or related area
Preferred:- Understanding of Med Device concepts
- Familiarity with ISO 13485, GDP, GMP concept
- Have a good understanding of engineering and quality concepts / theories
- Knowledge of Risk Based and statistical concepts.
- Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
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.