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
What you will do:
Will work within the Quality Systems team, under general supervision, with responsibility to ensure an effective and efficient management and release of documentation, this includes, but is not limited to the following duties:
- Will verify for accurate completion of change requests, and other Design History Documentation in onePLM.
- Will function as onePLM Administrator by supplying access to users to PLM system.
- Will provide customer service to users by supplying training and support to users.
- Will complete onePLM administrative tasks by supporting the PLM Help Queue.
- Will provide coaching, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes
- Will lead input, support and knowledge of the process for integration into SAP.
- Will be a Control of Records Retention Coordinator which will include communication, retrieval, storage and decision making with the service provider.
- Will lead and continue training users in onePLM.
- Will perform changes and updates to the PRMS system.
- Will perform updates and assistance to Technical Pubs and Production users of the Labelview Computer system and Prysm to maintain accurate On Demand Labels.
- Will identify and implement department process improvement projects.
- Will fulfill the process owner role for the procedures affecting Document Control.
- Will assist in maintaining documentation systems of other Stryker facilities (e.g. Stryker Limerick, Stryker Puerto Rico, Stryker Endoscopy.).
- Will coordinate with the Change Management Team and the business to prioritize change requests based on business needs.
- Will assist with Validation and testing of Change Management Process with the Change Management Team when changes are needed.
- Will train users on various systems and processes as needed.
- Will assist in retrieving documentation during internal and external audits.
- Will train new employees including the creation and maintenance of job aides and reference material.
What you will need:
- Candidate must have successfully completed third Level Qualification (Diploma in Quality Systems / Business Studies or Administration, or equivalent 2 year certification).
- Candidate must have at least 2- 4 year’s relevant experience in a regulated industry.
- Have an understanding of the following standards ISO 13485 and ISO 9000 and CFR Part 820 Quality System Regulations
- Knowledge of Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning)
- Must possess strong interpersonal skills including written and oral communication
- Must be able to communicate / present to large groups of people
- Must be able to bring tasks through to completion with minimal supervision.
- Must have the ability to prioritize work and keep detailed and confidential records.
- Problem solving skills
- Demonstrated ability to work independently
- Experience in working in a compliance risk situation
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com
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