$120,450 - $176,660; not specified; not specified ...
Medical device fda/european regulatory requirements
Quality management systems (qms)
Iso 14971 risk management
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies
Job Summary
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies.
Lead Risk Management and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit), and mitigations.
Provide expert guidance in the review of technical documentation and development of test, production acceptance criteria, and process validation protocols.
Matching Summary
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies.
Salary
$120,450 - $176,660; Not specified; Not specified
Skills & Requirements
Must-have
Medical device FDA/European regulatory requirements
Quality Management Systems (QMS)
ISO 14971 Risk Management
Design verification and validation
Process validation protocols
Supplier risk management
Nice-to-have
Customer success focus
Innovation and collaboration
Respectful interaction
Open and honest communication
Integrity in actions
Key Requirements
Bachelor's Degree in Engineering or related field
7-10 years of experience
Practical knowledge of FDA Quality System Regulations, ISO 13485