Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally.

Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.

Stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com.

Job Description:
Provide support to ensure the efficient operation of Quality Systems Administration processes including Device History Record Archiving, External Industry Standard Maintenance and Supplier change Notification
• Divisional responsibility for computer systems configuration management and administration for systems such as ERP (Oracle) and Documentation Systems (Windchill).
• Provide technical oversight of systems Change Control activities.
• Additional responsibilities include change control management of procedural documentation and Engineering Change Notices (ECNs) through electronic systems.
• Ensure overall compliance with document control requirements and systems data integrity.
• Manage Lead and/or support activities for multifunctional process improvements and systems integration projects.
• Generate training materials associated with the systems and processes used in the department.
• Provide comprehensive formal instruction on system use at all SO locations.
• Provide technical support to system developers during implementation and validation of system modifications.
• Manage and improve Divisional change control activities for QMS documentation, Drawing ECNs through integrated computer systems.
• Device History Record (DHR) archiving process including the direct supervision of the document scanning operation, status reporting and exception resolution.
• Ensure overall compliance to data integrity as well as document and change control requirements.
• Manage activities for process improvements and Divisional systems integration as well as participate in continuous improvement activities and process re-engineering projects in support of Stryker Orthopaedics' Continuous Improvement initiatives.
• Deliver divisional training on systems and/or processes related to ECN, ECR, and documentation.
• Track, monitor and prepare divisional systems metrics for management review.
• Interact with personnel in US and international plants within all disciplines.

Qualifications:
• Comprehensive knowledge and experience with all systems and processes used by Quality Systems Administration
• Knowledge of regulatory requirements: ISO 13485, Quality System Regulation 21 CFR 820 and Medical Device Directive.
• Demonstrated project management experience; capability to lead teams across the U.S. and international plants to achieve global process improvement efforts using project management tools.
• Demonstrated experience with Word, Excel, Visio, and Microsoft Project
• Demonstrated technical understanding of electronic systems such as document management, ERP systems.
• Demonstrated ability to create and deliver successful training to system users.
• Demonstrated experience processing and drawing ECNs, Guidsheets and other QMS documentation through electronic document management systems and ERP system.
• Demonstrated ability to independently troubleshoot technical issues with the electronic systems and processes used with the Quality System Administration function.
• Demonstrated experience in item creation and maintenance activities in an electronic ERP (Oracle) system.
• Demonstrated ability to problem solve and manage multiple tasks while assisting internal customers.

Education:
• Bachelor's Degree in Business, Information Technology or related science field with training in computer systems administration.
• Training in business and/or technical writing is a plus.

Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce. To read more about Stryker, please visit our website at www.stryker.jobs. Additional Information Reference Code:10150BR. Contact Information: Stryker www.stryker.com

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