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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.

  • Supervisory Responsibilities

  • Mentor and guide more junior technical resources

What you will need:

Basic Qualifications:

  • Bachelor’s Degree

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

Preferred Qualifications:

  • 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

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