Document Control Administrator

About the Company

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance the lives of patients worldwide and high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values: Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

Responsibilities

• Support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines.
• Adhere to company policies and procedures and all safety and quality requirements, including Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, and other regulatory requirements.
• Provide administrator support for change record implementation in line 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 review.
• Compile and complete quality records, reports, and documentation ensuring Good Documentation Practices (GDP) are applied.
• Review Device History Record (DHR) in accordance with applicable procedures and Good Documentation Practices.
• Assist the Quality department during audits.
• Provide data and analysis to other departments.
• Perform other duties as required.
• Expand skill base through on-the-job training, cross-training, and classroom instruction.
• Drive improvements in process quality and identify and escalate quality non-conformances.
• Adhere to Integer Core Beliefs, Safety and Quality requirements, and applicable regulations described in the quality management system (QMS).

Requirements

• Minimum Education: High school graduate or equivalent may be required.
• Experience in administration activities preferred.
• Minimum Experience: 2-3 years of experience.
• Skills developed through on-the-job training.
• Capable of working under moderate supervision.

Skills

• Leadership: Accountable for own contribution.
• Communication: Effective communication skills (both oral and written), uses communication skills to exchange important information.
• Organizational: Strong organizational skills, including time management and ability to prioritize and meet deadlines.
• Computer Operation: General computer operation skills (e.g., Microsoft Teams, Excel, Word).
• Attention to Detail: When reviewing and preparing documents.
• Problem Solving: Capable of recognizing and solving routine problems without supervision.
• Specialized Knowledge: Working knowledge of electronic documentation systems, understanding of Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820), office management, and administration skills.

How You Will Be Measured

• Safety is our highest priority; you are an active supporter of the Integer Environmental, Health & Safety programs.
• Live the Integer Values through leading by example.
• Assist the site in achieving its annual goals for safety, quality, delivery, cost, and inventory.
• Achieve all Goals and Objectives assigned.

Pay

Salary range for this position is $20.23-$29.67 per hour.

Benefits

• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility to participate in the 401(k) plan with company matching contributions.
• 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.