Base: $79,000.00 - $127,650.00; bonus/equity: not ...
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Experience with iso 13485 compliance
Hands-on design verification and validation
Risk management in accordance with iso 14971
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Johnson & Johnson is seeking a Senior Quality Engineer for Design Assurance specifically for the Shockwave Reducer system based in New Brighton, Minnesota. The ideal candidate will possess significant experience in the medical device industry, particularly in quality assurance, and will be responsible for ensuring compliance with regulatory requirements throughout the product development lifecycle.
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Job Summary
Johnson & Johnson is committed to healthcare innovation and improving patient outcomes.
The Senior Quality Engineer will ensure compliance with quality systems and regulatory requirements.
This role offers opportunities for professional growth within a dynamic team focused on advanced cardiovascular solutions.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Senior Quality Engineer for Design Assurance specifically for the Shockwave Reducer system based in New Brighton, Minnesota. The ideal candidate will possess significant experience in the medical device industry, particularly in quality assurance, and will be responsible for ensuring compliance with regulatory requirements throughout the product development lifecycle.
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Salary
Base: $79,000.00 - $127,650.00; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Experience with ISO 13485 compliance
Hands-on Design Verification and Validation
Risk Management in accordance with ISO 14971
Nice-to-have
Experience with Class II or Class III devices
Familiarity with balloon catheter devices
Knowledge of human factors engineering
Key Requirements
Bachelor's degree in biomedical/mechanical engineering
5+ years of medical device industry experience
Experience supporting regulatory inspections and audits