Job Summary: Under the direction of the Risk Management/Quality Assurance Director, the Document Control Specialist is responsible for the control and maintenance of all controlled documents pertaining to the quality management system, production, and production support systems. The specialist administers the document change control system. This position maintains quality management system, product, and support documentation in compliance with domestic and international regulations and industry standards.

Responsibilities/Duties:

DOCUMENT APPROVAL AND DISTRIBUTION

• Maintain master file for all controlled documents
• Maintain history file for all controlled documents
• Maintain document control procedures and instructions, filing system, and records
• Maintain proper identification of controlled documents, such as identification numbers, revisions levels, status, approval date, obsolete date, etc.
• Assign document numbers and maintain database/tracking system for numbers (Document Index)
• Maintain record and distribute appropriate documents to satellite files. Initiate self audits of satellite files and update records, as necessary.
• Document the approval date
• Provide control of obsolete documents
• Enter required information in the Enterprise Resource Planning system, i.e., Bill of Materials, documents, etc.

CHANGE CONTROL

• Assign Change Order numbers. Maintain database/tracking system for Change Orders.
• Initiate Change Orders, as needed
• Assist with formulation of Change Orders
• Process Change Orders
• Review Change Orders for accuracy and completeness
• Circulate, track, and follow-up on approval of Change Orders
• Implement approved document changes
• Distribute new revision documents
• Maintain archive file for old revision and obsolete documents
• Maintain history file of Change Orders
• Maintain revision history of all controlled documents

OTHER DUTIES

• Assist with format and formulation of controlled documents
• Maintain database/tracking system
• Assign identification numbers and maintain databases/tracking system, e.g., Design History File, Editorial Review, Validation, etc.
• Maintain Shop Order folders and completed Shop Order file. Review Shop Order folders for accuracy and completeness. Distribute Shop Orders. File completed Shop Orders.
• Produce copies of drawings and documents upon request, per document control procedures and instructions
• Work with Drafting to maintain controlled drawings and graphics
• Maintain Bill of Materials and document references in the Enterprise Resource Planning (ERP) system.
• Maintain the master file and history file for documents of external origin, i.e., domestic and international standards
• Maintain the Document Control Archive Room
• Provide word processing support, as needed
• Publish quality data reports for Management Review and other reports, as needed
• Complete special projects as assigned by the Director of RM/QA
• Assist RM/QA to promote and improve compliance and support the company quality policy, quality objectives, industry standards, and regulatory requirements
• Observe all company safety policies and practices

Minimum Qualifications:

• High school diploma or equivalent.
• Excellent computer skills, including word processing, database, spreadsheets, Adobe Acrobat
• Accurate computer keyboard/typing skills
• Excellent attention to detail, problem solving skills, and high level of accuracy are required
• Ability to file and maintain records in a manner that will assure documents are accurate, legible, readily identifiable, and easily retrieved
• Good spelling and grammar skills

Preferred Background:

• Familiarity with domestic and international medical device regulations, preferred
• In depth knowledge of document control and change control principles, techniques, and methods
• Experience working in Document Control Setting
• Familiarity with CAD and graphics programs
• Good organization and prioritization skills
• Good interpersonal skills
• Good communication skills
• Good problem-solving skills

Preferred Experience:

• Strong experience and background working in a Document Control setting, medical device manufacturing most preferred
• Experience with copy machines, scanners, and printers
• Experience with manufacturing planning system(s)

Job Type: Full-time

Pay: $20.00 - $24.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Employee stock ownership plan
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Quality control: 1 year (Preferred)

Ability to Commute:

• South Salt Lake, UT 84115 (Required)

Ability to Relocate:

• South Salt Lake, UT 84115: Relocate before starting work (Required)

Work Location: In person