Compensation: ideally up to $100k
Reports to: President & CEO
Client: ATA Inc.
Location: West GTA
At Advanced Test and Automation we develop unique technology for thermal and fluid pressure component validation in the Automotive industry. This is combined with a strong background in software development, data acquisition & control and a passion for testing.
During the COVID-19 crisis ATA has applied know-how in fluids and pneumatics to help design, assemble and test ventilator modules. This is an area of great need that we are proud to support with timely expertise and excellence. Join us and support Canada’s response against COVID-19!
Ventilator component manufacturing requires clean facilities and practices. You will be required to wear a face mask, hair net, lab coat and gloves when inside the manufacturing facility. Social distancing measures are in effect as the health and safety of all staff, and bio cleanliness of our products are of utmost importance.
KEY FUNCTIONS & RESPONSIBILITIES: The specific responsibilities of the role, while not limited to, include:
Manage QA and test staff and their activities to ensure adherence to producing a quality product and to conform to the Quality Management System.
Develop and maintain submissions to regulatory agencies & customers required to allow products to be sold in all regions and markets. (FDA, CE, Health Canada)
Develop and maintain the Quality Management System and supporting procedures capable of growing to meet ISO 9001:2015, ISO 13485, as well as FDA (QSR), European (CE Mark), and Health Canada (CAN-ISO 13485) requirements in the future
Manage auditing activities from the different regulatory agencies including FDA, Health Canada and other agencies
Assist as required to develop project documentation (for example, risk plans) as required for inclusion in regulatory submissions
Provide responses to regulatory agencies regarding product information or issues.
Train staff in regulatory policies or procedures.
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
QUALIFICATIONS & EXPERIENCE:
Following are the minimum requirements for the position:
Regulary affairs/medical device background
ideally 7+ years experience
Excellent understanding of Google Sheets and Gmail.
Strong time management skills with the ability to effectively manage multiple priorities and activities.
Experience working with the ISO 9001 quality standard is desirable.
Working experience in a clinical environment is an asset.
Training in quality assurance and auditing is desirable.
Knowledge of quality and regulatory standards (ISO 9001, ISO 13485, FDA QSR, etc.) is an asset
Experience with all aspects of the development lifecycle
Regulatory Affairs and Quality Assurance certifications an asset
The STORY Group is committed to fair and accessible employment practices. Upon request, suitable accommodations are available under the Accessibility for Ontarians with Disabilities Act (AODA) to applicants invited to an interview.