Document Control Administator

Integer • Plymouth, MN

6d

About The Position

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.

Requirements

• Minimum Education: Diploma / or equivalent in administration preferred .
• Minimum Experience: 3-4 years of experience.
• Developed specialized skills in their area and other related areas.
• Capable of working under minimum Supervision.
• Leadership Provides informal guidance and support to junior team members and other users .
• Effective communication skills (both oral and written)
• Responsible for explaining technical information or data.
• 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 providing solutions to problems in situations that are infrequently occurring.
• Proficient Understanding of Electronic documentation systems, Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820), and Office Management and Administration skills

Responsibilities

• 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 practices
• 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).
• Embed Quality within your daily work life – “I own Quality.”
• You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS).

Benefits

• Base wages
• Cash-based incentive program
• Overtime pay
• Shift differentials
• Call-in pay
• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Adoption benefits
• Parental leave
• Supplemental life insurance
• Critical illness insurance
• Hospital indemnity insurance
• Accident insurance
• 401(k) plan with company matching contributions
• 80 hours (10 days) of company designated holidays
• Annual allotment of paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree