Document Control Coordinator

SGS Consulting; Carlsbad (CA); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Paid vacations

Medical insurance

401K savings plan

Life insurance

Disability insurance

Job summary

A professional services firm in California seeks a detail-oriented individual to maintain Device Master Records and assist with quality system documentation. Candidates should possess a high school education or equivalent, with one to two years of relevant experience, and be capable of working under minimal supervision. This role entails managing databases, processing change orders, and ensuring compliance. Attractive benefits and a supportive work environment are offered.

Qualifications

• One to two years of previous regulatory/quality or related experience.
• Six months on-the-job training or equivalent combination of education and experience.

Responsibilities

• Creation and maintenance of Device Master Records and Device History Records.
• Assist with leading weekly change control meetings and processing change orders.
• Maintain the company intranet and document revisions.

Education

High School education or equivalent

Job description

About US: SGS is a New Jersey headquartered end-to-end Professional Services firm servicing a diverse Fortune clientele. SGS is a Equal Opportunity Employer and prides itself as a employee oriented organization that considers an ensemble of all employee satisfaction elements crucial to organizational and employee growth. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits.

Job Description

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.

Qualifications

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.

Additional Information

Job Summary

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