Medical Device Quality Assurance Expert
1 week ago
About the Role:
The Design Assurance Quality Engineer III is responsible for providing quality engineering support to new product development projects and sustaining projects for current products on the market. This role involves developing, establishing, and maintaining quality-engineering methodologies, systems, and practices that meet Boston Scientific's requirements.
This is a hybrid position based out of Montreal, Canada with an expectation to be in the office a minimum of three days per week.
Your Responsibilities:
- Provide quality and compliance input to project teams for project decisions and deliverables.
- Support software verification and validation activities for new products.
- Perform risk evaluation and associated management activities related to product development.
- Support product cybersecurity assessments in conjunction with a cross-functional team.
- Provide quality and compliance input for post-market product sustaining activities.
- Apply technical skills in identifying, prioritizing, communicating, and resolving quality issues.
- Collaborate within a team to identify and implement effective controls to support development or maintenance of products.
- Capable of working independently on highly specialized projects with long-range objectives.
Required Qualifications:
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related field.
- Minimum 6 years of medical device engineering experience.
- In-depth familiarity with FDA, ISO, MDD, EU MDR, and medical device industry quality requirements.
- Strong communication and presentation skills.
Estimated Salary Range:$120,000 - $180,000 per year
About Boston Scientific:
Boston Scientific is a leading global medical technology company committed to advancing science for life. Our mission is to transform lives through innovative medical solutions that improve patient outcomes, create value for our customers, and support our employees and the communities we serve.
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