Vesalius Cardiovascular is a Vancouver-based medical device start-up specializing in the treatment of mitral regurgitation through novel medical devices.
We are designing and developing a revolutionary approach to the treatment of mitral regurgitation and currently have an exciting new opening for an experienced Quality Assurance Manager in Vancouver, BC. Please add a cover letter to your application.
The Quality Assurance Manager will be an advocate for quality medical devices development for the entire organization, focusing on the Design Controls and Risk Management.
Under the supervision of the Director of Engineering, the Quality Assurance Manager will be responsible for the overall design & development, implementation, and maintenance of the organization’s Quality Management System (QMS). Additional responsibilities will include developing and executing tests, investigating and assisting in problem analysis, and resolving quality issues related to the development of product lines.
The Quality Assurance Manager responsibilities will include, but are not limited to, the following:
- Initiate, document, and maintain the corporate wide Quality Management System (QMS).
- Lead or support Risk Management (in accordance with ISO 14971) evaluation of new products being developed.
- Help establish both design control and risk management documents in compliance with applicable standards.
- Set up a suitable supplier qualification and management program.
- Ensure the strategy for document and records management is well-defined and implemented.
- Deploy and maintain training matrices of the corporate Quality Documents.
- Handle multiple projects and tasks, from product inception through product launch and maintenance.
- Play an active role in the processes to ensure products meet quality standards and are consistent with the QMS.
- Help establish manufacturing inspection, sampling, and statistical process control methods and procedures to assure quality of manufactured products.
- Assure compliance to in-house and external specifications and standards.
- Identify and highlight quality issues by providing input to drive corrective actions to problems identified.
- Perform/lead root cause analysis to determine corrective action(s), as necessary.
- Lead in the development of Failure Mode and Effects Analysis (FMEA).
- Train internal staff on latest quality techniques.
The ideal candidate should have:
- Bachelors Degree in Mechanical Engineering or Biomedical Engineering. Master’s is a plus.
- A minimum of 4 years in the quality (design controls) and/or regulatory medical device industry or equivalent.
- Strong knowledge, understanding and experience with implementing ISO quality management system for medical devices (ISO 13485:2016) and US FDA Quality System Regulation (21 CFR 820).
- Experience in structural-heart related medical devices is considered a very strong asset.
- Working knowledge of risk management skills and requirements (e.g. FMEA and ISO 14971).
- Experience as Auditor of internal and external quality management systems is considered a plus.
- ASQ, CQE or CQA certification is an asset.
- Project Management experience.
- Start-up experience (working in a fast-paced environment) is a plus.
- Excellent technical report writing and strong ability to understand and analyze technical documents.
- Exceptional communication and interpersonal skills, with the ability to comfortably communicate at various levels in the organization, both internally and externally.
- Proven abilities in project and time management to ensure completion of tasks on a priority basis.
- High level of critical thinking and problem-solving skills.
- Self motivated with a strong work ethic.
- Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, microscopes, manometers, pull test and other inspection equipment.
- Demonstrated knowledge in Quality System Regulations.
Compensation, Perks & Benefits:
Vesalius Cardiovascular offers an attractive compensation package. Our engineering lab. is centrally located (VGH) and includes:
- Access to a full-service gym
- Access to numerous green spaces, and lounge areas, and nearby restaurants
- Fun and Relaxed Work Environment
- Easy access to transit
For more information on our company, please visit www.vesaliuscardio.com
Job Type: Full-time
- Risk Management: 2 years (Preferred)
- Medical Device: 5 years (Required)
- QMS: 5 years (Required)
- Start-up: 5 years (Preferred)
- Vancouver, BC (Required)