You have responsibility for tracking periodic review of Quality Management System (QMS) documents and notifying process owners of upcoming reviews.
You are experienced in reviewing the AG notification of change database daily and notifying affected areas of changes.
Being responsible for the regulatory and industry standards list which includes placing orders for new and updated revisions is second nature to you.
You work within an ERP system, updating BOM changes.
You use your technical writing skills to create or modify documents into template formats.
Does this sound like you? If so, we’d like to talk to you.
Medela is seeking a Change Control Specialist to join our team at our McHenry, IL location.
Medela was founded in 1961 by Olle Larsson in Zug, Switzerland, Medela continues to grow under the ownership of the Larsson family. Medela exists to advance human health and wellbeing through knowledge-based and innovative human milk and medical vacuum solutions. In Medela we have two business segments, Human Milk and Healthcare. The common denominator for the two segments is the medical vacuum. We have developed and progressed our core competencies over the past 50 years and turned them into high quality and innovative products, in both segments.
Medela's US-based manufacturing and development facility is headquartered in McHenry, Illinois with an additional facility in Elgin, Illinois. www.medela.com
What We Offer our Change Control Specialist:
Excellent salary
Comprehensive benefits plan, which is affordable to our employees
401K with match
Pension Plan
Generous PTO package, including package
Education and Critical Skills-Change Control Specialist
Associate’s degree preferred
Minimum five years’ experience in document control, change control or a related role required
Understands the operating "flow" in a plant, including general understanding of the related manufacturing and document change management systems/processes
Self-motivated individual with the ability to work independently
Strong attention to detail with ability to catch errors made by others
Team and customer oriented
Organized with the ability to multitask; able to prioritize and handle a fast-paced environment
Knowledge of MS Office (Excel, Word, etc.) is required
Excellent verbal and written communication skills
Ability to manage multiple conflicting priorities
Experience working in an environment with global objectives
Essential Functions-Change Control Specialist:
Reviews Medela AG notification of change database daily and notifies affected areas of changes
Assembles monthly department metrics
Maintains item set-up templates within ERP system to reflect the most current parameters
Uses technical writing ability and works with subject matter experts to create or modify documents into template formats
Responsible for tracking periodic review of Quality Management System (QMS) documents and notifying process owners of upcoming reviews to ensure timely completion
Responsible for maintaining the regulatory and industry standards list which includes placing orders for new and updated revisions
Responsible for maintaining the QMS index
Responsible for placing department orders for supplies
Mentors appropriate individuals on the change control process and procedures
Responsible for document distribution to appropriate areas
Assigns new part numbers, article numbers, UPC numbers, and document numbers
Arranges documentation approval meetings and/or routes critical packages for approval as needed
Reviews submitted change orders to ensure the package is complete, accurate, and that all procedures were followed.
Updates ERP system (bill of material changes, item master data, ECO maintenance)
Creation of the Change Request (CR) and Functional Design (FD)
Creation of test scripts and ensuring test execution and documentation
Medela Core Behaviors
Put the customer first. Be solution oriented. Take ownership. Strive for excellence.
