Job Description:
Design Quality Engineer III
US-CA-Redwood City, Remote
Job ID: 2024-4634
Type: Regular Full-Time
# of Openings: 1
Category: Quality
US-CA-Redwood City, Remote
Overview
The Software Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing, with an emphasis on design controls pertaining to software development. This is a hands-on role where the Software Design Quality Engineer will apply diversified knowledge of software design and development as per 62304, software verification, recognized software development standards, and quality principles and practices for implantable medical devices and accessories.
- Follow procedures to guide software and systems development and ensure best engineering practice compliance with relevant regulatory requirements.
- Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
- Risk Management
- Cyber security risk assessment
- Systems Validation
- Quality Investigations
- Traceability
- Software Design
- Configuration management
- Lead in cybersecurity, post-market vulnerability assessments, and other risk management processes.
- Support internal and external regulatory audits and other quality assurance functions.
- Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.
- Demonstrate understanding of software best practices.
- Work with departments to discuss system gaps, fixes, design solutions, and risks.
- Perform other duties as required.
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Responsibilities
- 5+ years of Quality/Regulatory experience in a medical device or other regulated industry
- Bachelor's degree in a technical or science major
Qualifications
- 3 years’ experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
- Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
- Experience working with Cloud based infrastructure and systems that process, store, and distribute large sets of data continuously.
- Have working knowledge of the following:
- Highly developed written and oral communication skills and be able to work in a team environment.
- Must have good problem-solving skills and be able to work independently.
- Working knowledge of Corrective Action & Prevention methodology.
- Must be organized, detail-oriented and adaptable according to evolving business needs.
- ASQ Certified Software Quality Engineer (CSQE) preferred.
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.
PI250757494
Salary:
$89,188.00More jobs in Redwood City, California
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