Senior Document Control Coordinator

Integer • Plymouth, MN

2d

About The Position

The Senior Document Control Coordinator supports and performs documentation administration activities within the Quality function, following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Quality system guidelines. The role works under clearly defined procedures and/or with minimal supervision, and supports document control, records management, quality documentation, audits, and other departments.

The position includes administrator support for change-record implementation, control of controlled-document distribution and retrieval, management of access to on-site and off-site records, annual record disposition reviews, and review of Device History Records (DHRs). The coordinator also helps train personnel on systems and processes, provides guidance and analysis to other departments, and contributes to quality improvements and the achievement of quality objectives and metrics.

The role requires adherence to company policies, safety and quality requirements, the Quality Management System (QMS), applicable regulatory requirements, and Integer’s core values. Quality is embedded in daily work, including identifying and escalating non-conformances and contributing to corrective and preventive actions. Performance is measured in part by supporting safety, quality, delivery, cost, and inventory goals, living Integer’s values, and achieving assigned objectives.

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 administrator support for change-record implementation in line with standard operating procedures.
• Control the distribution and retrieval of controlled documents, including electronic files.
• 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.
• Review Device History Records (DHRs) in accordance with applicable procedures and documentation practices.
• 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.
• Continually seek improvements in process quality.
• Identify and escalate quality non-conformances to support company quality objectives and business metrics.
• Adhere to company policies, safety and quality requirements, the QMS, and applicable regulations.
• 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

• Base wages and a cash-based incentive program.
• Overtime pay, shift differentials, and call-in pay when applicable.
• Medical, dental, vision, disability, and life insurance with immediate eligibility.
• Adoption benefits.
• Parental leave available after one year.
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility for the 401(k) plan with company matching contributions.
• 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: Senior
• Education Level: No Education Listed