Why RA/QA at Stryker?Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-teamWe are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.comStryker is hiring a Senior Specialist, Quality Management Systems - Change Control who will work with the Global QMS team to provide leadership and direction for all aspects of the QMS projects from initiation to completion and will engage with stakeholders impacted by the project, including end users, with the aim of consistently enhancing our quality standards and business efficacy.Who we want -
Detail-oriented process improvers . Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness.
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.
Monitoring completion of post release tasks to ensure completion in a timely manner.
Drive initiatives for continuous improvement.
Drive cross-plant projects and participate in corporate project teams in areas of change control.
Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.
Lead and support the Change Analyst function across sites.
Mentors and coaches Change Analysts.
Support the Change Manager role, where applicable.
Support in training needs related to the change control process.
Support in the preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits.
What you will need:
Bachelor's degree is required but preferred in a science or Engineering discipline.
Minimum of 3 years of work experience in a regulated environment, preferred medical devices.
About StrykerOur benefits:
12 paid holidays annually
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.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)About StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at stryker.com. (http:)Know someone at Stryker?Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page (https://careers.stryker.com/referrals/)Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.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.