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- Up to $28 an hour
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Document Control Coordinator - Senior

Noramtec Consultants Americas -
Norfolk, VA

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Job Details

Full-time | Contract
Up to $28 an hour
2 days ago

Benefits

Health insurance
Dental insurance
401(k)
On-the-job training
Vision insurance

Qualifications

Interpersonal skills
Labeling
High school diploma or GED
Change management
Documentation tools
Attention to detail
Organizational skills
FDA regulations

Full Job Description

Our client is a global leader in musculoskeletal healthcare. They design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products. Their products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Alongside some of the world's top healthcare professionals, they help deliver new possibilities to patients.

Under minimal supervision, maintains Device Master Record and Device History Records as part of the quality system, and maintains department databases.

Principal Duties and Responsibilities

Creation of Device Master Records such as routers, master cross references, and bill of materials within the ERP system.
Maintain Device Master Records and Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc.
Assist with new part number assignment process by creating new part numbers within ERP system for design teams and Marketing department.
Assist with leading weekly change control meetings and processing of all change orders within the quality system.
Handle distribution of all change orders (engineering, specification, and labeling) to appropriate departments.
Assist with the maintenance of the company intranet, Livelink/SAP web based software to ensure the most current document revisions are available at all points of use.
Assist with processing Instructions for Use and all labeling intended for domestic and international distribution. This includes approval of product labeling using the label producer software.
Maintenance of various databases to ensure compliance to regulations such as indices used for procedures, drawings etc.
Assist with preparing and organizing documents for offsite storage archival and/or archival onto CD.
Maintain storage logs.
Process and distribute various document requests to departments as needed.
Complete various projects as assigned by the supervisor in addition to general filing and copying.

Expected Areas of Competence (i.e. KSAs)

Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship.
Good verbal and written communication skills.
Good word processing and database skills.
Outstanding organizational skills and high attention to detail.
Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices a plus.

Education/ Experience Requirements

High School education or equivalent plus one to two years previous regulatory/quality or related experience and six months on-the-job training, or an equivalent combination of education and experience.

Pay: Up to $28.00 per hour

Benefits:

401(k)
Dental insurance
Health insurance
Vision insurance

Work Location: In person

Quick Apply

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Document Control Coordinator - Senior

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