Coordinator I Document Control

About the role

This position is responsible for providing Quality support for access management of a document control system.

What You’ll Work On

• Process documentation system access requests and ensures timely completion in accordance with established procedures.
• Review requests for completeness, accuracy, approvals, and compliance requirements.
• Grant, modify, and remove user access within documentation and quality management systems.
• Provide customer support and guidance regarding access-related inquiries and requests.
• Troubleshoot and resolve documentation system access issues and incidents.
• Maintain accurate records and documentation of access management activities.
• Support audits, inspections, and periodic access reviews.
• Drive continuous improvement initiatives to enhance process efficiency and customer service.
• Collaborate with cross-functional stakeholders to ensure compliant and effective access management processes.

Qualifications

• High School Diploma/GED.
• 1-3 years' experience.
• Prior experience with documentation control or product surveillance systems preferred, e.g. Windchill.
• Knowledge of FDA, GMP, and ISO 13485.
• Solid computer skills and report writing skills.
• Prior medical device experience preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Preferred Qualifications

• Prior experience with documentation control systems, e.g. Windchill preferred.

Pay

The base pay for this position is $17.85 – $35.75 per hour. In specific locations, the pay range may vary from the range posted.