Senior Quality Assurance Specialist
6 days ago
About the Role:
The Design Quality Assurance Specialist will provide quality engineering support to new product development projects and sustaining projects for current products on the market.
Key Responsibilities Include:
- Developing a deep understanding of Design Controls, Risk Management, and Usability for Medical Devices.
- Providing 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.
- Collaborating with cross-functional teams to identify and implement effective controls to support the development or maintenance of products that meet internal and external requirements.
- Maintaining compliance with all quality requirements and ensuring that quality is built into all aspects of work.
- Supporting internal and external regulatory audits as required.
Required Qualifications:
- Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent.
- 0-2 years of related work experience.
- Medical device experience.
- Proficiency in Microsoft Office Suite.
Estimated Salary Range: $80,000 - $110,000 per year, depending on location and experience.
Location: This role can be based in various locations where Boston Scientific has offices.
About Boston Scientific:
Boston Scientific is a leading medical technology company that develops innovative solutions to improve patient outcomes worldwide.
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