Document Control Coordinator

Integer Holdings Corporation • Plymouth, MN

1d • $20 - $30

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, with minimal supervision. The role administers change records, controls document distribution and retrieval, manages records and document access, supports quality documentation and audits, and provides guidance and training to other departments. The coordinator is expected to follow company safety, quality, regulatory, and operating requirements and to contribute to process improvements and quality objectives.

The position also supports the Integer Environmental, Health & Safety programs, models Integer’s values, and assists the site in achieving goals for safety, quality, delivery, cost, and inventory. The employee expands their skills through on-the-job training, cross-training, and classroom instruction.

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, including 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.
• Proficient 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

• Follow company policies, procedures, safety and quality requirements, including QMS, EMS, FDA regulations, and other applicable regulatory requirements.
• Provide administrative support for change record implementation in accordance with standard operating procedures.
• Control 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 other documentation in accordance with Good Documentation Practices (GDP).
• Review Device History Records (DHR) in accordance with applicable procedures and Good 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.
• Continually seek improvements in process quality.
• 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 QMS regulations.
• Support corrective and preventive actions and contribute to quality KPIs and the journey to 5 Sigma.
• Actively support Integer Environmental, Health & Safety programs and help the site achieve annual safety, quality, delivery, cost, and inventory goals.
• Achieve assigned goals and objectives.
• Perform other duties as required.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Adoption benefits
• Parental leave after one year
• Optional supplemental life insurance
• Optional critical illness insurance
• Optional hospital indemnity insurance
• Optional accident insurance
• 401(k) plan with company matching contributions
• 80 hours (10 days) of company-designated holidays per year
• Annual allotment of paid time off
• Cash-based incentive program
• Overtime pay, when applicable
• Shift differentials, when applicable
• Call-in pay, when applicable

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED