Job Description

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. 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

Who we want

* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
* Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
* Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions

What you will do

As a Senior Document Control Specialist you will primarily be responsible for the oversight & assessment of changes to the quality management system. As a Senior Specialist you will oversee and ensure that changes to quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes.

* You will work within the QMS team, under general supervision ensures compliance to Change Control processes and procedures and is responsible for, but not limited to.
* You will lead & execute the change control board review forums. Participate in multi-site and global forums.
* You will liaise with relevant functional groups, facilitate and mentor teams through all stages of the change control process. Supports and coaches the change owners and initiators.
* You will act as SME ensuring users provide the necessary rigor to the Master Control system content including maintaining a live document with all relevant evidence attached, in a timely manner.
* You will ensure adequate training is developed, maintained, and provided to all users of change control process & systems.
* You will manage & monitor site Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved
* You will interface between divisions & GQO sites, and functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
* You will identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.

What you need

* Bachelors degree in Engineering or related discipline.
* Minimum of 2 years experience in areas of Quality Management Systems or equivalent in a highly regulated environment. (e.g. CAPA, Audits, Management review, Quality Planning) highly preferred.
* Experience with Master Control system highly preferred.
* Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
* Thorough knowledge and understanding of US and International Medical Device Regulations highly preferred.
* (REMOTE with limits to preferred locations: MN, TN, IN, GA)

LI-Remote

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