Document Control

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway- you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Review and approval of documents prior to use, including managing the Document Change Request process (ensuring accuracy of document content, revision levels are accurate, and documents are available at each point of use)

Document Control Clerk: As a document control clerk, you will use your exceptional eye for detail to review paper documents for accuracy, scan them into our system, link them to the appropriate customer order, and store them securely. You'll insure compliance for our quality management system with document creation, revision and obsoleting and route those items for electronic approval and signature using Adobe Sign. You'll exercise your written communication skills with MS Word for document creation and formatting.

The ideal candidate will have the following responsibilities

• Understands and can explain ISO 13485 and the FDA 21 CFR Part 820 and how they drive our document system
• Reviews QMS records for accuracy and exercises good documentation practices; including compliance to ISO 13485 and FDA 21 CFR Part 820, as well as internal procedures
• Scans records and audits the file location and legibility of scanned QMS records, and links files to Global Shop (ERP System)
• Conducts a complete review of shipping documentation prior to shipment release to the customer
• Reviews and routes QMS documentation for approval prior to issue
• Maintains the accuracy of documents at points of use, specifically verifying the most recent version is displayed
• Prevents the unintended use of obsolete documents, and applies suitable identification to them if they are retained for any purpose

To be successful, this candidate must have

• Strong written and verbal communication, prioritization and organizational skills
• Ability to lift 50 pounds
• Stamina to sit for prolonged periods of time working on a computer
• Excellent writing and proof reading 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

Benefits

We offer completive wages and amazing benefits, some of which are:

• Benefits starting on DAY 1:
• Health, dental, & 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
• Benefits starting on the first of the month following 30 days of employment:
• 401k retirement savings plan with a 50% company match up to a 3% match

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.