Who Are We?
Evasc Medical Systems design and manufacturer medical devices that aim to provide novel solutions for the endovascular repair of cerebral aneurysms and to provide a much higher standard of care and rate of successful treatment outcomes than previously possible.
Who We Are Looking For?
We are currently looking for a Quality Systems/Quality Assurance Coordinator. In this role, you provide support to our regulatory affairs, manufacturing and engineering teams while maintaining effective operation of Evasc’s Quality Management System. This position requires high levels of organization and attention to detail.
Key Responsibilities may include:
- Maintains Quality System Documentation in accordance with ISO 13485
- Maintains Vendor files, including new vendor approvals
- Vendor Audits
- Reviews and updates standards annually
- Conducting and scheduling Internal audits
- Perform training on the QMS
- NCR, CAPA, PAR review and approval
- Track, coordinate, verify effectiveness of CAPA’s and PAR’s
- Review product returns, feedback and complaints
- Reviews part/document revisions, deviations and expiry dates on work orders
- Help coordinate document control activities as needed
- Interacting with engineering and manufacturing on related quality issues
- Performing other duties as assigned
This position may require extended hours, travel, and duties outside of the scope of responsibilities, as needed.
To perform the job successfully, an individual should demonstrate the following:
- Be extremely organized and able to multitask
- Have excellent attention to detail
- Effectively communicate between teams and ability to work independently
- Is consistently at work, ensures work responsibilities are covered when absent. Arrives at meetings on time
- Is able to follow instructions, responds to management direction, takes responsibility for own actions, keeps commitments
- Treats people with respect, inspires the trust of others, works with integrity and ethically and upholds organizational values
- Follows policies and procedures, completes tasks correctly and on time and supports the organization's goals and values
- Balances team and individual responsibilities, exhibits objectivity and openness to others' views, gives and welcomes feedback
- Observes safety and security procedures
Education and/or Experience:
- Minimum of a High school diploma and 5 years Quality Assurance/Quality Systems experience or Post Secondary diploma or degree in a science field with 1-3 years Quality Assurance/Quality Systems experience
- Standards and regulatory knowledge (knowledge of ISO 13485, ISO 14971, 21CFR 820, Health Canada’s requirements and Europe’s’ Medical Device Regulation an asset)
- Good command of the English language, written and oral
- Proficiency in related software applications, such as Word and Excel
- Science or medical device related experience
Please include a cover letter with your application.
Wage Depending On Experience.
Job Type: Full-time, Permanent.
Please note that due to our current COVID-19 procedures all interviews will be performed remotely, therefore access to, and knowledge of video conferencing is required.