Responsibilities may include the following and other duties may be assigned .
Work with suppliers and obtain material composition/material of concern information through supplier declarations and/or testing.
Actively monitor regulatory and industry Materials of Concern requirements and incorporate updates into Medtronic Materials of Concern (MoC) List.
Ensure availability of product composition information including hazardous or restricted substances to identify safety data and labeling requirements compliance.
Use EHS&S evaluation tools in earliest stage development for product design and change management to address restrictions and limitations.
Management of Safety Data Sheets and Labels for compliance requires product composition analysis and access to final product content materials.
Enhance business understanding, use of, and access to the centrally maintained Medtronic MoC List to meet regulatory requirements for product development, product change management, product packaging, regulator and customer requirements and business use.
Maintained completed documentation and related product content for business needs and compliance.
Centrally maintain Safety Data Sheet documentation for all products and improve access to controlled documents for business use and in response to regulator requests and reviews.
Creating data base templates and collating the data .
Work with suppliers to quickly address any non-conformances.Should assist in material testing and verification.
Must Have:
Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8+ years of quality systems experience.
Strong communication skills, both oral and written.
Ability to comprehend principles of engineering, physiology and medical device use.
Previous customer-facing and/or project management experience is a plus.
Comfortable working with international and multi-cultural department and groups in different time zones .
Accurate and delivers quality work, with a sense of urgency.
Ability to work well under pressure and maintain positive, enthusiastic attitude.
Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountablity .
Should be able to use Solid work, CREO,CAD tools flawlessly ,understand the drawings and the Bill of materials.
Overview on the standards like REACH, RoHS, California P65 & WEEE etc.
Understanding of 2D drawings per ASME Standards with knowledge on GD&T.
Nice to Haves:
Previous experience working with global team (Aerospace,Defence, Med device, automobile preferably).
ASQ Quality certification.
Hand on experience on Minitab tools .
Exposure in auditing to FDA Quality System Regulation & ISO 13485.
