Quality Assurance Specialist

This position will play a key role within the Regulatory Affairs Department to maintain documentation compliance
Meeting requirements for U.S. and International requirements as defined in FDA Regulations, ISO 9001 Standards, ISO 13485:2016, Medical Device Directives, Canadian Medical Device Regulations and other International Regulations.

Bachelor’s degree in Health Care or Sciences required,
Master’s degree preferred.
Minimum of 5 to 8 years of medical device or pharmaceutical call center/complaint experience is required.
Understand the medical device/pharmaceutical industry.
Understands FDA regulations and reporting requirement for adverse effects, medical device complaints and medical communications.
Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations is a plus.
Specific health impact of various types of products and potential adverse reactions/interactions of medical products.
Identify the critical issues of problems or opportunities using appropriate information.
Must apply the knowledge of our client’s core business capabilities to help the organization meet its goals and desired outcomes.
Must be able to review systems, processes and policies to ensure compliance with required good manufacturing and clinical practices.
Identify and understand relevant trends, opportunities, needs, and market direction within the medical device/pharmaceutical industry
Must be able to drive to or fly to various meetings/client sites with limited overnight stays. Some international travel may be required

All your information will be kept confidential according to EEO guidelines.