Principal Specialist, Quality Management Systems
Location: Cary, IL
Salary: $65.00 USD Hourly – $90.00 USD Hourly
Description: Our client is currently seeking a Principal Specialist, Quality Management Systems for a 12 month contract.
Thorough knowledge and understanding of US and International Medical Device Regulations, including MDSAP, with direct experience in US 510(k) and EU Class II devices.
Strong knowledge of Quality Systems (Measurement, Analysis, and Improvement; Adverse Event and Advisory Reporting; Purchasing; Design and Development; Production and Service Controls, etc.)
Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience.
Strong communication, project management and influencing skills.
Ability to plan, organize, and implement multiple concurrent tasks.
Strong interpersonal skills, written, oral communication and negotiations skills.
Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
Demonstrated ability to work in cross-functional team environments.
Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.
Act with a customer service/stakeholder-focused approach.
Leverages excellent interpersonal keys to achieve desired outcomes.
Experience in compliance risk situations.
Experience in technical writing and procedure development.
Computer literacy.
Some travel may be required.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively “Judge”) to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge’s Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!