Quality Associate

2 weeks ago

Toronto, Canada Conavi Full time

Imagine your future at Conavi

Join our collaborative team in the design, manufacture, and sale of an innovative intravascular imaging system to improve cardiac care.

Conavi Medical's Novasight Hybrid System enables simultaneous imaging of a patient's coronary arteries using both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT) technologies.

If you would like to be a part of a growing and talented team that is making a difference in healthcare, we are currently looking for a Quality Assurance Associate to contribute to the administration and continuous improvement of Conavi's Quality Management System (QMS) in compliance with the applicable standards for the design and manufacture of medical devices such as ISO13485 and the regulatory requirements including Medical Device Single Audit Program (MDSAP).

**In this position, you will**:
Support the administration of Quality processes and procedures such as Corrective and Preventative Actions (CAPA) and customer feedback with document updates, migration of information to eQMS, validation, etc.;
Co-ordinate the internal staff training program including assigning courses as well as the preparation and distribution of status reports
Administer the document and record control program according to established QMS procedures including assigning document numbers, ensuring adherence to revision control, circulation, and then storage of approved documents
Support the Measurement, Improvement and Analysis as well as Post-Market Surveillance programs through activities such as data verification, reporting data gaps and discrepancies, and contributing to trending analysis
Participate in external quality and regulatory audits with event scheduling and the provision of data
Contribute to the implementation of improvements to the QMS that drive a lean, effective, functional, and compliant system including reviewing and updating documents and training
Support regulatory activities as required under the direction of Regulatory staff
Promote and instill principles of quality in any collaborations with others in the organization
Participate in opportunities to develop quality and medical device knowledge
Participate, and adhere to occupational health and safety initiatives and requirements

**You possess the following qualifications**:
Post-secondary education ideally with a post-graduate program in Quality and/or Regulatory
Prior working experience in a Quality Assurance function ideally operating under ISO quality standards (e.g., 13485), regulatory requirements (e.g., FDA), and a CGMP environment
Demonstrated skills in managing quality documentation and records
Strong communications and organizational skills while possessing initiative and working collaboratively

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