Quality Associate

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 talented team that is making a difference in healthcare, we are currently backfilling for a Quality 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

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

· Proficient in computer applications including Microsoft Office (Outlook, Excel, Word, Access) and an eQMS

Key competencies include communications, collaborations, organizational, and self-initiative

Conavi Medical values everyone and their contributions. We value diversity and encourages applications from all qualified candidates. Please let us know if you require accommodations on any of the grounds protected by the Ontario Human Rights Code during the recruitment process.

Please submit a resume directly to Conavi Medical through the Careers section of our website at www.conavi.com. We thank all candidates for their interest but only those selected for an interview will be contacted.