Job Description

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.
* Supervisory Responsibilities
* Mentor and guide more junior technical resources

What you will need:

Basic Qualifications:

* Bachelors Degree
* 2+ years of document control, engineering, and/or quality experience in a highly regulated industry (medical device, pharmaceutical, aeronautics, or automotive)

Preferred Qualifications:

* Bachelors 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