Design Quality Assurance Engineer
1 month ago
At Boston Scientific, we're committed to advancing science for life by developing innovative medical solutions that improve patient outcomes. As a Quality Assurance Engineer II, you'll play a critical role in ensuring the quality and compliance of our medical devices.
About the Role:
The Quality Assurance Engineer II provides quality engineering support to new product development projects and sustaining projects for current products on the market. This includes developing and maintaining quality-engineering methodologies, systems, and practices that meet regulatory requirements.
- Develops a deep understanding of Design Controls, Risk Management, and Usability for Medical Devices.
- Provides quality and compliance input to project teams for project decisions and deliverables, including Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling.
- Provides quality and compliance input for post-market product sustaining activities, such as design changes, NCEPs, CAPAs, PIRs, Field Signals Evaluations, and Field Actions.
- Applies technical skills, including sound, systematic problem-solving methodologies, to identify, prioritize, communicate, and resolve quality issues.
- Collaborates with a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
- Supports internal and external regulatory audits as required.
Required Qualifications:
- Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent.
- 3+ years of work experience relating to quality assurance in a highly regulated industry.
- Competent with use of Microsoft Office Suite.
- Excellent organizational and planning skills.
As a leader in medical science for over 40 years, we're committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
So, if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.
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