Document Control Specialist

3 days ago


Grand Rapids, Michigan, United States SunMed Group Holdings, LLC dba AirLife Full time
Job Overview

The Document Control Coordinator is a vital role within the SunMed Group Holdings, LLC dba AirLife team, responsible for ensuring the accuracy and compliance of documentation across various departments. This position requires attention to detail, strong organizational skills, and excellent communication abilities.

About Us

SunMed Group Holdings, LLC dba AirLife is a premier manufacturer of high-quality breathing consumables, dedicated to improving the quality of every breath. Our commitment to excellence is reflected in our Quality Management System and compliance to Regulatory Requirements.

Job Responsibilities

  • Documentation Management: Utilize ERP systems to maintain databases, update product statuses, and manage information obsoleting.
  • Collaboration: Work with Marketing Product Management teams to ensure part number and data base accuracy and current content.
  • Inventory Management: Manage the final disposition process and process contributors of product inventory as products reach their end-of-life process and become discontinued.
  • Quality Assurance: Perform updates to documentation through an FDA and ISO13485 quality management system (QMS).
  • Reporting: Identify and report item, inventory level, and order information to other departments.
  • Expedited Documentation: Expedite documentation to support product end-of-life activities for purchased, molded, assembled devices through product lifecycle.
  • Filing Management: File management of specification Bill of Material (BOM) and associated technical documentation and Instructions For Use (IFU).

Requirements

  • Knowledge: Acquired through education, certifications, training, experience.
  • Skills:
    • Basic computer skills, including experience with word processing, spreadsheets, flowcharting, and relational databases.
    • Strong attention to detail. Work well under minimum supervision.
    • Familiarity with electronic document management systems (EDMS).
    • Flexible with management of records across different departments.
  • Experience: 2-3 years' experience in a medical device, drug, or related ISO regulated field.

Benefits

  • Competitive Salary
  • $63,000 - $80,000 per year
  • Benefits Package

Company Culture

AirLife values diversity, equity, inclusion, and advancement (DEIA), promoting a positive work environment and striving for excellence in customer satisfaction and product quality.



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