Document Control Specialist - ISO & FDA Compliance

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 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.