Senior Software Quality Assurance Engineer
United StatesFull-TimeSenior
Salary110,000 - 150,000 USD per year
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Job Details
- Experience
- 5+ years
- Required Skills
- Risk Management
Requirements
- BS in Computer Engineering, Computer Science, Electrical Engineering, or related degree.
- 5+ years of experience developing software or firmware in the medical device industry.
- Demonstrated proficiency meeting IEC 62304 requirements.
- In-depth knowledge of ISO 13485 and 21 CFR Part 820.
- Full accountability for representing Quality Engineering on project teams.
- Ability to present procedural requirements and design deliverables during audits.
- Strong leadership and influencing skills.
- Excellent written and verbal communication skills.
- Strong prioritization and planning abilities.
Responsibilities
- Provide technical leadership on software/firmware product development teams.
- Own risk management documentation, design requirements, architecture specifications, and design verification/validation.
- Chair the change control board, managing change requests and defects.
- Lead investigations into software/firmware-related complaints, nonconformities, and CAPAs.
- Deliver technical feedback through code reviews.
- Ensure compliance with development procedures and non-product software validation.
- Support regulatory audits as a subject matter expert.
- Build working relationships with R&D, Clinical, Regulatory Affairs, and Operations.
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