Document Control

Precision Edge Surgical Products Company LLC; Sault Ste. Marie (MI); On-site; USD 40,000 - 56,000; Full time

Benefits offered by this job

Health, dental, & vision insurance

Disability coverage

Life and AD&D insurance

401k plan with company match

Job summary

Precision Edge Surgical Products Company LLC is seeking a Detail-Oriented Document Control Clerk to review and scan records, link them to orders, and ensure QMS compliance. You will manage revisions, obsolescence, and electronic approvals using Adobe Sign.

You will apply knowledge of ISO 13485 and FDA 21 CFR Part 820, maintain document accuracy, and collaborate with multiple departments to support a robust quality system. Proficiency in MS Word and ERP usage is required.

Qualifications

• Experience with quality management systems (QMS) and document control.
• Understanding of ISO 13485 and FDA 21 CFR Part 820.
• Ability to ensure accuracy and proper revision control of documents.
• Familiarity with electronic approvals and signatures.
• Proficiency in MS Word formatting and document creation.

Responsibilities

• Review and approve documents prior to use and manage revision levels.
• Scan and link documents to customer orders in the ERP system.
• Ensure compliance with QMS and regulatory requirements.
• Review shipping documents before release to customers.
• Prevent use of obsolete documents and manage obsolescence.

Skills

Written communication

Verbal communication

Prioritization

Organization

Physical stamina

Typing/document control

Analytical problem solving

Team collaboration

Attention to detail

Multitasking

Tools

Global Shop ERP

MS Word

Excel

Access

Adobe Acrobat

Job description

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.

• Understand 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.

• 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 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.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class.

Welcome to the biggest small business you’ll ever find. Part of Berkshire Hathaway, Marmon is a global industrial organization made of 11 industry groups with 30K employees and $12 billion in annual revenue. As leaders in their respective industries, our 120+ companies thrive on an independent mindset and entrepreneurial spirit. At the same time, they benefit from being part of our industry groups—where they’re able to tap into the expertise and insights of other Marmon companies. While we’re all unique, we all share a common commitment to doing things that matter, leading at every level, and winning a better way. When you work at Marmon, you're advancing our everyday world and beyond. Our engineering solutions help millions around the world stay connected, healthy, and safe. Wherever you're at in your career, our people and resources will help you go further. As you grow your skills, you can also move up and around our 120+ companies. Work at a place you can stand behind. We show up to win every day, uphold the highest ethical standards, and always look to put each other in the best position to win.