Quality Validation Engineer
Quality Validation Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
About Us
As a Quality & Validation Engineer you will play a crucial role in mitigating product risks and accelerating quality and regulatory processes through rigorous testing and documentation. You will develop and execute verification and validation plans and protocols ensure compliance with medical device regulations and work crossfunctionally to maintain the highest standards of product quality reliability safety and effectiveness.
This is a hybrid position open to candidates based in Vancouver Toronto or the Bay Area.
Help reshape the world through proactive healthcare while working with cuttingedge technology and high performing teams with deep expertise join us to make a difference in peoples lives!
What Youll Do
- Develop and implement V&V strategies for AIbased medical imaging products to meet FDA and other regulatory standards .
- Design execute and document test plans protocols and reports (IQ OQ PQ) to QA software components and systems.
- Collaborate with AI researchers software engineers and regulatory teams to ensure seamless integration of quality and compliance processes.
- Conduct risk assessments failure mode analyses and root cause investigations to enhance product reliability.
- Maintain documentation in compliance with ISOIECand other relevant medical device regulations.
- Establish and monitor quality control processes including software verification and validation activities.
- Support regulatory submissions by providing test documentations risk analyses and other compliance documentation.
- Participate in internal and external audits ensuring adherence to quality management system (QMS) requirements.
- Drive continuous improvement initiatives to enhance testing efficiency and regulatory compliance.
What Youll Bring
- Bachelors or Masters degree in Biomedical Engineering Electrical Engineering Computer Science or a related field.
- Handson knowledge of Python programming language test frameworks and git
- Handson experience with test automation tools and CI/CD like Jenkins Github Actions
- 3 years of experience in quality assurance validation or regulatory compliance within the medical device or healthcare industry.
- Experience with software verification and validation for AI/MLbased medical applications.
- Handson experience with statistical analysis tools and validation methodologies.
- Excellent problemsolving skills and attention to detail.
- Strong technical writing skills for regulatory documentation.
- Ability to work effectively in a crossfunctional team environment.
Nice to Have
- Knowledge of FDA regulations including 21 CFR Part 820 21 CFR Part 11 and ISO 13485.
- Experience with machine learning model performance testing and algorithmic bias assessment.
- Knowledge of Good Automated Manufacturing Practice (GAMP 5 and computer system validation (CSV).
- Previous experience with software development lifecycle (SDLC) in a regulated environment.
- Familiarity with risk management principles (ISO 14971 and medical imaging standards (DICOM PACS).
- Familiarity with cybersecurity considerations for medical AI applications.
Our Values
First: we are Pioneers
- Transforming healthcare requires divergent thinking bias for action disciplined experimentation and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.
Second: we are PlatformBuilders
- Were always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of whats ahead in a mindset of ownership and duty to our mission.
Above all: we are Patients
- We could all be the next person who walks through our very doors seeking clarity or peace of mind. We are proud of our impact on our patients lives and we wont stop till everyone can benefit from our work.
What We Offer
- An avenue to make a positive impact on peoples lives and their health
- We believe in preventative healthcare for everyone including our team Prenuvo provides free wholebody scans to each team member
- Growth opportunities are at the heart of our people journey were doing big things with bright minds there is no single path to success it can be shaped along the way
- Building strong relationships is at the core of everything we do our team gets together each week to connect share and socialize
- Recognizing time away to restore is vital to our wellbeing we have a flexible vacation policy and we will encourage you to use it
- We offer a comprehensive benefits package including health dental vision including Mental Health coverage to support you and your family
- The base salary for this role ranges from $140000 $160000 in local currency depending upon experience
We are an equalopportunity employer and value diversity at our company. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status.
As part of the hiring process successful candidates will undergo a background check in compliance to applicable federal provincial and state rules.
Please be advised that official communication from our recruitment team will only come from our authorized domain . If you are contacted by a recruiter please ensure their email address ends with @. We do not use thirdparty recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent please report it immediately to
Employment Type
Full Time
