Quality Assurance Specialist

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
• Proficient in computer applications including Microsoft Office (Outlook, Excel, Word, Access) and an eQMS
• Strong communications and organizational skills while possessing initiative and working collaboratively

Conavi Medical values diversity and encourages applications from all qualified candidates including women, visible minorities, indigenous people, and persons with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

Please submit a cover letter and resume directly to Conavi Medical through the Careers section of our website at www.conavi.com.