Quality Assurance Engineer II
3 weeks ago
About the Role:
The Design Quality Assurance Engineer II individual provides quality engineering support to new product development projects and sustaining projects for current products on the market. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Your Responsibilities:
- Develops understanding of Design Controls, Risk Management, and Usability for Medical Devices.
- Provides quality and compliance input to project teams for project decisions and deliverables.
- Collaborates within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external 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.
- Medical device experience.
- Competent with use of Microsoft Office Suite.
Preferred Qualifications:
- Focus on detailed work with emphasis on accuracy and completeness.
- Excellent organizational and planning skills; drives for results.
- Strong communication (oral and written) and presentation skills.
- High energy problem solver capable of driving items to closure.
- Ability to collaborate and work on a global team.
About Boston Scientific:
As a leader in medical science for more than 40 years, we are 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.
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