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Document Control Manager Optovue
THIS JOB HAS EXPIRED
This position reports to the Vice President of Regulatory Affairs and Quality Assurance and is responsible for technical documentation procedures and practices. The Document control manager ensures proper document controls and records tracking processes consistent with a regulated environment. The role may conduct assessments of complex data projects involving records management and recommend solutions. The incumbent is current on the field?s concepts, practices, and procedures. May lead or supervise the work of others.
Responsibilities:
Creates and implements quality procedures and works with cross-functional teams
Trains others on the Quality Management System and compliant change process.
Manages the document review and approval system
Tracks document change requests to ensure review and approval timelines are maintained
Publishes effective guidance documents and maintains masters as well as controlled documents.
Maintains the document control database and provides associated metrics
Provides tracking and trending of preventive and corrective actions
Generates associated metrics.
Other duties as assigned by management.
Requirements:
BS/BA degree in a scientific discipline preferred or equivalent experience
Minimum of three years of relatable experience in the medical device industry.
Experience with Windchill? or other electronic PLM software.
Demonstrated proficiency in GDP, GMP and ISO 9001.
Good familiarity with FDA Quality Management Systems is essential.
| Location: | 41752 Christy Street Fremont, CA 94538 United States |
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THIS JOB HAS EXPIRED
Optovue
All Jobs: at Optovue| Web Site: | www.optovue.com |
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| Headquarters: | 41752 Christy Street Fremont, CA 94538 United States |
| Industry: | Medical Devices and Equipment |
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