Coordinator II Document Control

Main Purpose

The Coordinator II, Document Control position is responsible for effective change request administration, properly applied configuration control concepts, providing technical support to project teams as required, maintenance of controlled documentation and records, maintenance of documentation databases and enforcing adherence to written documentation policies and procedures.

Main Responsibilities

• Assure effective change order administration and ensure all change requests comply with procedure requirements.
• Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation.
• Coordinate implementation of change requests with all affected areas/facilities.
• Prioritize and schedule completion of approved change orders.
• Work with remote facilities as necessary to assist in changes that affect multiple locations.
• Maintain appropriate logs and records.
• Provide assistance to change requestors in updating documents, creating or updating Bills of Materials and submitting change requests.
• Maintain accurate configuration control: control part numbers and revision level assignments.
• Maintain product configurations by ensuring accuracy of Bills of Materials.
• Control Device Master Records.
• Maintain item master accuracy by updating additions, deletions, and other changes as required.
• Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met.
• Distribute notifications and updated documents to applicable areas, as required.
• Proofread documents for accuracy and adherence to policies, as necessary.
• Support Engineering projects to ensure accurate product configuration and documentation of new products.
• Support project teams to ensure change requests are implemented to meet deadlines.
• Support Custom Device Requests to ensure accurate documentation, as necessary.
• Create change orders for personnel as requested.
• Provide support to archiving activities.
• Support Customer requests such as retrieval of old history including down rev. documents and device history, provide copies of procedures and/or procedure books as necessary, update distribution lists.
• Evaluate activities and identify areas of improvement and carry out improvement activities.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

Education: High School Diploma / GED

Experience: Minimum 4 years, 4-5 years related work experience.

• Solid computer skills and report writing skills.
• 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.