Quality Assurance Specialist Conavi Medical
See your future at Conavi!
Join our collaborative and entrepreneurial team designing and manufacturing minimally invasive innovative imaging solutions to improve cardiac care around the world.
Conavi Medical’s Foresight ICE catheter is the world's first intracardiac echo system with the capability to acquire 2D and 3D images with a broad field-of-view that includes both side-viewing and forward-looking capabilities. Our Novasight Hybrid System enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT).
If you would like to be a part of our growing and talented team that is making a difference, we are currently looking for a Quality Assurance Specialist to c ontribute to the development and maintenance of Conavi’s Quality Management System (QMS) in compliance with applicable standards such as ISO13485 and regulatory requirements of agencies including but not limited to Health Canada, US FDA, European Commission and Japan PDMA. You will also perform quality assurance review activities to ensure product quality.
In this position, you will:
- Maintain the Conavi Quality Manual through the authoring of new content and updating existing content as well as ensuring the format and records associated with the Manual are current and compliant
- Create or support company functions in developing Quality Management System controlled documentation such as Standard Operating Procedures (SOP’s) and company policies
- Facilitate the corrective action and preventative action (CAPA) process by tracking, monitoring and reporting on CAPA status and actions plans through to CAPA closure
- Facilitate the internal quality audit program including performing some audits as well as ensuring the completion of all audits and the production of the subsequent reports
- Administer the company’s complaint handling process by monitoring complaints, proposed changes or customer feedback progress appropriately through the RTC system and are adequately addressed
- Participate in external quality and regulatory audits by gathering data and contributing to the closing out of audit observations as required
- Participate in supplier audits by gathering and reviewing supplier audit information and documenting supplier audit reports
- Perform final product quality assurance review and acceptance to ensure that each production run, lot or batch of finished devices meets acceptance criteria
- Contribute to the development and delivery of quality training for staff across the organization
- Identify and introduce improvements in quality and business processes
- Promote and instill the principles of quality in collaborations with colleagues across the organization
- Participate in opportunities to develop quality and medical device business knowledge
- Participate, and adhere to, health and safety initiatives and requirements
You possess the following qualifications:
- Bachelor’s degree or diploma in Science or Engineering
- Post-graduate diploma or certification in Quality is an asset
- Previous experience working in Quality Assurance positions operating under Quality Management Systems in the medical device or pharmaceutical manufacturing companies (approx. 3+ years)
- Understanding and working knowledge of ISO Quality Standards (13485), FDA Quality System Regulation and/or Good Manufacturing Practices
- Demonstrated skills and knowledge in preparing and updating quality related documentation, and quality audits
- Proficient computer application skills including Microsoft Office (Outlook, Excel, Word, Access)
- Teamwork-oriented approach to achieving goals
- Strong verbal and written communication skills
- Excellent organizational ability and attention to detail
- Ability to multi-task, prioritize duties and execute tasks in a timely manner
- Strong self-initiative and work ethic
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.