Stryker Document Management Specialist in Tempe, Arizona
Who we want:
Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Dedicated achievers . People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Stryker is hiring a Senior Specialist, Quality Management Systems , in Tempe, AZ.
What you will do:
The Senior Specialist, Quality Management Systems has a key role in implementing quality systems to support change control. The Senior Specialist, Quality Management Systems also plays a key role in document control activities to ensure conformance to customer requirements and set forth regulatory standards.
Execute the Enterprise Change Request Process (schedule meeting, conduct pre-reviews, establish agenda, issue minutes).
Ensure Division and plant quality systems processes are in adherence to the Change Control Process.
Maintain and administer access to PLM in cooperation with GIT
Process owner for tracking, coordination and implementation of corporate documents for division.
Develop and conduct training programs for division change management.
Ensures regulations are adhered to from set forth standards.
Ensures that all revision changes are enforced according to Change Control Process.
Prepares and arranges for release of approved document revisions.
Maintains all records and documents required by company policies.
Ensure adherence to best practices for applications and services to promote leveraging of common solutions and unified data sources.
Participate in critical problem solving and advanced troubleshooting.
Lead the establishment, automation and reporting of department and electronic system metrics.
Analyze metrics and make recommendations.
Department expert for Agile PLM system.
Manage projects as assigned and determined by Department manager.
Mentor and guide more junior technical resources
What you will need:
2+ years of document control, engineering, and/or quality experience in a highly regulated industry (medical device, pharmaceutical, aeronautics, or automotive)
Bachelor’s Degree in a technical field is preferred (i.e. Science or Engineering)
4+ years of document control experience in a highly regulated industry (medical device, pharmaceutical, aeronautics, or automotive)
Familiarity/understanding of configuration management and/or change management
Experience in the medical device industry is preferred
Proficient with PLM (Product Life Cycle Management) systems (Agile, Windchill or equivalent)
Experience with ISO certification audits
Proficient in Microsoft Office software, internet, e-mail, faxing and scanning
Demonstrated ability to set priorities, meet deadlines and multi-task
Demonstrated ability to read and interpret specifications, reports, standards, guidance documents, and procedures
Demonstrated ability to prepare and analyze reports
Demonstrated ability to communicate effectively both oral and written
Demonstrated ability to interface with both technical and non-technical personnel
Demonstrated ability to work effectively in a team environment with shifting priorities and timeliness