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Senior Specialist Change Management

Stryker 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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Senior Specialist Change Management - Military Veterans

at Stryker Corporation

Arlington, TN