Senior Document Control Coordinator

Integer Holdings Corporation • Plymouth, MN

4d • $25 - $36

About The Position

The Senior Document Control Coordinator supports and performs documentation administration activities within the Quality function, following Good Manufacturing Practices (GMP), Quality system guidelines, and defined procedures. The role provides administrator support for change record implementation; controls the distribution, retrieval, access, and disposition of controlled documents and records; compiles and reviews quality documentation; and supports audits and other departments. The coordinator also trains personnel in the proper use of systems and processes and provides subject matter guidance to junior team members and other users.

The position is expected to follow company policies and safety, quality, environmental, security, and regulatory requirements, including the Quality Management System (QMS), Environmental and Security Management Systems (EMS), FDA regulations, and applicable local requirements. It contributes to process improvement, identification and escalation of quality non-conformances, corrective and preventive actions, and the achievement of quality objectives and KPIs.

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 to 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.
• Proficient understanding of office management and administration skills.

Nice To Haves

• Diploma or equivalent in administration.

Responsibilities

• Follow company policies, procedures, safety and quality requirements, QMS and EMS requirements, FDA regulations, and other applicable regulatory requirements.
• Provide administrator support for change record implementation in accordance with standard operating procedures.
• Control 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 in accordance with Good Documentation Practices (GDP).
• Review Device History Records (DHRs) 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 to improve process quality.
• Identify and escalate quality non-conformances to support company quality objectives and 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 company's journey to 5 Sigma.
• Support site goals for safety, quality, delivery, cost, and inventory, and 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 available after one year
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance
• 401(k) plan with company matching contributions, with immediate eligibility
• 80 hours (10 days) of company-designated holidays per year
• Annual allotment of paid time off
• Cash-based incentive program
• Overtime pay, shift differentials, and call-in pay when applicable

What This Job Offers

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