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Job Details
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!
- 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
- 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
- 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.
About the Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers... Read more