Senior Document Control Coordinator

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 minimum supervision. Adhere to company policies and procedures and all safety and quality requirements including, but not limited to:
Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required in your location. 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 / 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 Assist the Quality department during audits. Provide support / guidance and analysis to other departments.

Train personnel in proper techniques to utilize systems, and processes. Performs 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. 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). You embed Quality within your daily work life – “Iown Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma.

The specific measures listed below may be subject to change and are not intended to be an all‑inclusive list. 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.

• Minimum Education:
  
  Diploma / or equivalent in administration preferred.
• Minimum Experience:
  
  4+ years of experience.
• Expertise developed through on the job training and job experience.
• Special
  
  Skills:
  
  Leadership Provides subject matter guidance for junior team members and other users.
• Effective communication skills (both oral and written) Advance communication skills to communicate complex detailed information.
• 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 Capable of identifying creative solutions for atypical problems.
• Specialized Knowledge:
  Proficient Understanding of Electronic documentation systems Quality Management Systems (e.g., ISO
  9001, ISO
  13485, FDA 21
  
  CFR Part 820)…