Associate Document Control Administrator
Integer Holdings Corporation
Summary
The primary purpose of this position is to support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines. Carries out responsibilities under clearly defined procedures and/or under close supervision.
Job description
What you will do in this role
The primary purpose of this position is to support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines. Carries out responsibilities under clearly defined procedures and/or under close supervision.
- Adhere to company policies and procedures and all safety and quality requirements including Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), 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
- Manage and control access to on-site and off-site records and documents
- Perform annual record disposition review
- Compile/complete quality records, reports and/or 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
- Perform other duties as required
Grow on the job and help others succeed
- Expands skill base through on-the-job training, cross training, and classroom instruction
- Provide data to other departments
Ensure Alignment on the Corporate Strategic Initiatives
- Continually seeks to drive improvements in process quality
- Identifies and escalates quality non-conformances to assist in achieving company quality objectives and key business metrics
- Adheres to Integer Core Beliefs, Safety and Quality requirements and applicable regulations described in the quality management system (QMS)
- Embed Quality within daily work life and assure adherence to the Quality Management System (QMS)
How you will be measured
- Safety is our highest priority; 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
What sets you apart
- Minimum Education: High school graduate or equivalent may be required
- Minimum Experience: 0-1 years of experience; entry level administrative duties; capable of working under close supervision
- Effective communication skills (both oral and written)
- Strong organizational skills (including time management and ability to prioritize and meet deadlines)
- General computer operation skills (e.g., Microsoft Teams, Excel, Word)
- Attention to detail when reviewing and preparing documents
- Problem solving: use existing procedures to solve problems and engage in continuous improvement activities
- Basic understanding of electronic documentation systems
- Basic understanding of Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA 21 CFR Part 820)
- Office management and administration skills
Requirements
- High school graduate or equivalent may be required
- 0-1 years of experience
- Entry level administrative duties
- Capable of working under close supervision
- Effective communication skills (both oral and written)
- Strong organizational skills including time management and ability to prioritize and meet deadlines
- General computer operation skills (e.g., Microsoft Teams, Excel, Word)
- Attention to detail when reviewing and preparing documents
- Problem solving using existing procedures and continuous improvement activities
- Basic understanding of electronic documentation systems
- Basic understanding of Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA 21 CFR Part 820)
- Office management and administration skills
Benefits
- Medical, Dental & Vision
- Disability Insurance
- Life Insurance
- Adoption Benefits
- Parental Leave
- Supplemental Life Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- 401(k) Matching
- Paid Time Off
- Company Holidays
Company overview
Integer Holdings Corporation (NYSE: ITGR) is one of the world's largest medical device contract development and manufacturing organizations (CDMO), serving as a strategic partner to leading medical device companies and OEMs globally. With an 80-year legacy of innovation, the company specializes in advanced medical device outsourcing across cardiac rhythm management, neuromodulation, and cardio and vascular markets. Integer operates through its two primary brands, Greatbatch Medical® and Lake Region Medical®, offering comprehensive solutions from product design and development to finished device manufacturing. The company's extensive product portfolio includes catheters, guidewires, delivery systems, implantable batteries, capacitors, and Class III medical devices, serving over 15 medical markets. With manufacturing facilities spanning four continents and more than 2.5 million square feet of production space, Integer provides vertically integrated supply chain solutions that help medical device companies accelerate time-to-market while maintaining uncompromising quality and regulatory compliance standards.