Document Control

Responsibilities

• Review and approve documents prior to use, including managing the Document Change Request process.
• Ensure accuracy of document content, revision levels are accurate, and documents are available at each point of use.
• Exercise written communication skills with MS Word for document creation and formatting.
• Understand and explain ISO 13485 and the FDA 21 CFR Part 820 and how they drive the document system.
• Scan records and audit the file location and legibility of scanned QMS records, linking files to Global Shop (ERP System).
• Conduct a complete review of shipping documentation prior to shipment release to the customer.
• Route QMS documentation for approval prior to issue.
• Maintain the accuracy of documents at points of use, specifically verifying the most recent version is displayed.
• Prevent the unintended use of obsolete documents, and apply suitable identification to them if they are retained for any purpose.

Requirements

• Strong written and verbal communication, prioritization, and organizational skills.
• Ability to lift 50 pounds and sit for prolonged periods of time working on a computer.
• Excellent writing and proofreading skills.
• A keen interest and ability to work on complex assignments in collaboration with various department system owners.
• Analytical problem-solving skills.
• Strong team skills and ability to work with others in a positive and collaborative manner.
• A demonstrated ability to work accurately, follow instructions/schedules/timelines, and handle multiple priorities.
• Basic to intermediate experience with MS Word, Excel, Access, and Adobe Acrobat.
• The ability to work well under minimal supervision.
• Flexibility to adapt to changes in priorities with little notice.

Qualifications

• High school diploma or equivalent.
• Experience in a similar role preferred.

Skills

• Strong written and verbal communication skills.
• Excellent writing and proofreading skills.
• Strong analytical problem-solving skills.
• Strong team skills and ability to work with others in a positive and collaborative manner.
• Basic to intermediate experience with MS Word, Excel, Access, and Adobe Acrobat.

Benefits

• Comprehensive health, dental, and vision insurance for employees, spouses, and dependent children up to age 26.
• Company-paid short and long-term disability coverage.
• Company-paid life and AD&D insurance.
• Voluntary life insurance for employee, spouse, and dependent children up to age 18.
• Vacation pay that accrues on a bi-weekly basis.
• Paid holidays.
• 401(k) retirement savings plan with a 50% company match up to a 3% match.

Pay

Competitive wages.

Schedule

Full-time.