Quality Documentation Specialist — GMP/ISO Focus

Integer Holdings; Plymouth (MN); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Disability insurance

401(k) with company matching

Paid time off and holidays

Parental leave

Job summary

Integer Holdings is seeking a documentation administrator to support the Quality function in a GMP/GDP environment. You will administer change records, control document access, and prepare quality records and reports.

Under defined procedures, you will review device history records, assist audits, and provide data to other departments while maintaining compliance with QMS and regulatory requirements.

Qualifications

• High school graduate or equivalent may be required; experience in administration preferred.
• 2–3 years of experience; skills developed on the job; ability to work under moderate supervision.
• Working knowledge of Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820) and electronic documentation systems.

Responsibilities

• Support and perform documentation administration within the Quality function, adhering to GMP and GDP guidelines.
• Follow clearly defined procedures or operate under moderate supervision.
• Adhere to Quality Management System requirements and regulatory requirements.
• Administer change records, control access to documents, and notify applicable functions of document changes.
• Assist audits and provide data/analysis to other departments.

Skills

Leadership

Effective communication

Time management

Organization

Office software

Attention to detail

Problem Solving

Education

High school diploma

Tools

Microsoft Teams

Excel

Word

Job description

Integer Holdings is seeking a documentation administrator to support the Quality function in a GMP/GDP environment. You will administer change records, control document access, and prepare quality records and reports.

Under defined procedures, you will review device history records, assist audits, and provide data to other departments while maintaining compliance with QMS and regulatory requirements.