Document Control Coordinator

Integer • Plymouth, MN

6d

About The Position

The Document Control Coordinator supports and performs documentation administration activities within the Quality function, following Good Manufacturing Practices (GMP), Quality system guidelines, and clearly defined procedures. The role provides administrator support for change record implementation, controls the distribution, retrieval, access, and disposition of documents and records, and helps ensure quality records and reports follow Good Documentation Practices (GDP). The coordinator reviews Device History Records (DHRs), supports the Quality department during audits, and provides guidance, analysis, and training to other departments and users.

The position adheres to company policies, safety and quality requirements, the Quality Management System (QMS), Environmental and Security Management Systems (EMS), FDA regulations, and other applicable regulatory requirements. The coordinator identifies and escalates quality non-conformances, supports corrective and preventive actions, contributes to quality objectives and KPIs, and continually seeks process improvements. The role also involves on-the-job and cross-training, supporting corporate strategic initiatives, and helping others succeed.

Performance is measured in part by supporting safety, quality, delivery, cost, and inventory goals; demonstrating Integer’s values; supporting Environmental, Health & Safety programs; and achieving assigned goals and objectives. The stated pay range is $20.23–$29.67 per hour.

Requirements

• Diploma or equivalent in administration preferred.
• At least 4 years of experience.
• Expertise developed through on-the-job training and job experience.
• Leadership skills, including providing subject-matter guidance to junior team members and other users.
• Effective oral and written communication skills, including the ability to communicate complex, detailed information.
• Strong organizational skills, including time management, prioritization, and meeting deadlines.
• General computer operation skills, such as Microsoft Teams, Excel, and Word.
• Attention to detail when reviewing and preparing documents.
• Problem-solving ability, including identifying creative solutions for atypical problems.
• Proficient understanding of electronic documentation systems.
• Understanding of Quality Management Systems, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
• Office management and administration skills.

Nice To Haves

• Diploma or equivalent in administration.

Responsibilities

• Support and perform documentation administration activities within the Quality function in accordance with GMP and Quality system guidelines.
• Provide administrative support for change record implementation in line with standard operating procedures.
• Control the distribution and retrieval of documents, including electronic files of controlled documents.
• Notify applicable functions when local external documents change, as required.
• Manage and control access to on-site and off-site records and documents.
• Perform annual record disposition reviews.
• Compile and complete quality records, reports, and documentation while applying Good Documentation Practices (GDP).
• Review Device History Records (DHRs) in accordance with applicable procedures and good documentation requirements.
• Assist the Quality department during audits.
• Provide support, guidance, and analysis to other departments.
• Train personnel in proper techniques for using systems and processes.
• Expand skills through on-the-job training, cross-training, and classroom instruction, and help others succeed.
• Support alignment with corporate strategic initiatives and continually seek process quality improvements.
• Identify and escalate quality non-conformances to support company quality objectives and key business metrics.
• Adhere to Integer Core Beliefs, safety and quality requirements, and applicable regulations described in the QMS.
• Support Integer Environmental, Health & Safety programs and site goals for safety, quality, delivery, cost, and inventory.
• Achieve assigned goals and objectives and perform other duties as required.

Benefits

• Cash-based incentive program supporting a pay-for-performance philosophy.
• Overtime pay, shift differentials, and call-in pay when applicable.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• Disability insurance.
• Life insurance.
• Adoption benefits.
• Parental leave available after one year.
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• 401(k) plan with company matching contributions; employees are immediately eligible to participate.
• 80 hours (10 days) of company-designated holidays per year.
• Annual allotment of paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed