Senior Document Control & Change Lead

Integer Holdings Corporation; Minneapolis (MN); On-site; USD 34,000 - 50,000; Full time

Job summary

Integer Holdings Corporation in Minnesota is seeking a qualified professional to manage Quality System Document Control. The role administers the Change Control Process, maintains records, and ensures compliance with FDA and related standards.

The position involves coordinating reviews, signing off on changes, and supporting audits while maintaining SharePoint documentation and retention processes.

Qualifications

• Technical Associate’s degree with 5-7 years experience in business or technical field OR Bachelor’s degree with 2 years of experience in related field.
• Specialized knowledge in Engineering and Documentation Control Systems.
• Ability to read and develop technical drawings/prints and strong technical writing skills.

Responsibilities

• Adheres to FDA regulations and quality requirements and company policies.
• Leads and maintains the Change Control Process with proper reviews and sign-off.
• Maintains data distribution systems and timely release of documentation.
• Participates in audits and manages file archives and the Change Control Database.
• Interfaces with originators to prepare documents and resolve discrepancies.

Skills

Document control

Technical writing

Reading drawings

Education

Technical Associate’s degree + 5-7 years

Bachelor’s degree + 2 years

Job description

Integer Holdings Corporation in Minnesota is seeking a qualified professional to manage Quality System Document Control. The role administers the Change Control Process, maintains records, and ensures compliance with FDA and related standards.

The position involves coordinating reviews, signing off on changes, and supporting audits while maintaining SharePoint documentation and retention processes.