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-team

We 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.com

What we want -

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation. ​

• Data translators. Highly effective communicators who can transform data findings into recommendations.

• Collaborators. Partners who listen to ideas, share thoughts, and work together to move the business forward

• Life learners . People who want to learn, grow, and develop within Stryker's broad scope of opportunities. This is a company you can grow with!

What you will do -

As a Senior Document Control Coordinator, you will support a documentation control program(s) in compliance with cGMP and Quality System (QS) requirements. Your primary responsible will be the administration of Product Lifecycle Management (PLM) system housing QMS documentation and change control records.

• Conduct cGMP and QS documentation control functions in compliance with established processes and procedures.

• Administer Product Lifecycle Management (PLM) system housing Quality Management System documentation and change control records.

• Process complex change tasks with attention to detail and in a timely manner.

• Update Manufacturing Execution System (MES) for approved revisions.

• Deliver proactive customer service and exhibit the ability to build expertise assisting internal customers in navigating processes related to document control and records.

• Maintain a scheduled periodic review of QMS documentation.

• Ensure proper archive, storage and retrieval of controlled documentation, maintaining master copies. and other documents not residing in the PLM system.

• Collaborate with internal customers and stakeholders to support compliance and the needs of the business

• Support internal and external audits, as advised by the Quality Systems team

• Participate in continuous improvement efforts

• Support GMP and GDP within Quality organization

• Perform other related duties, e.g., routine reporting, as assigned

What you need -

• 3+ years related experience - required

• High School Degree - required

• BS in business administration or related discipline - preferred

• Previous experience in document management and eSystem routing - preferred

• Work experience in a regulated environment (cGMP, cGDP and 21 CFR part 11 regulations) - - - preferred

• Working knowledge of document control and records processes.

• Computer literacy, including Microsoft Word, Excel and PowerPoint.

• Good communication and organizational skills

• Detailed oriented

• Dependable and willing to learn.

• Strong interpersonal skills with the ability to use tact and diplomacy.

• Physical Requirements: minimal physical activity, standing, walking, sitting, hearing, fingering, grasping, must be able to read and review quality control procedures.

• As a rule, the Sr. Document Control Coordinator is subject to controlled indoor conditions with some temperature change from occasional tasks outdoors or in the warehouse

• Mental Requirements: reading comprehension, critical thinking, problem solving, organization, communication, collaboration and d ata interpretation

About Stryker

Our 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 Stryker

Stryker 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.