This job has expired.
RESPONSIBILITIES:
A Kforce client is seeking to hire a Senior V&V Quality Engineer - Medical Device in Carlsbad, California (CA).Summary:The client is a growing Medical Device Technology company who is seeking a Senior V&V Software Quality Engineer. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus and Stock/RSU's. This position is hybrid remote. The Senior Quality Engineer will support Quality Assurance, R&D, Manufacturing Engineering, and Operations in the design and manufacture of Medical Devices, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), Etc.Responsibilities include:- Responsible for Quality Assurance for Electro-Mechanical Medical Devices containing software
- Contribute Software Quality activities for all software development life cycle activities including risk management, software configuration management, and software problem resolution
- Senior V&V Software Quality Engineers will support development and testing of product software to meet user and technical requirements and design specifications, for FDA and worldwide Regulatory Body regulations and guidance
- Perform day to day Software Quality activities to ensure that software and supporting test tools have been Verified and Validated (V&V), demonstrating that the software meets specification requirements and works as intended, per user needs, and design requirements
- Senior V&V Software Quality Engineers will manage Software Change Control to assess and disposition software defects and change requests
- Review and Approve Requirement and Design Documents, Unit Verification, Code Reviews, Software V&V Test Plans and Protocols, Test Reports, and Risk Management documents
REQUIREMENTS:
- Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, Biotechnology, Biomedical, or similar field
- 5-8+ years of relevant industry experience in software quality engineering and V&V experience
- Experience with Medical Device Software Development regulations such as IEC 62304 and FDA Guidance for software contained in medical devices such as consoles or other electro-mechanical medical equipment is required
- Quality engineering experience with medical devices containing software (Class II/Class B at minimum and Class III/Class C preferred)
- Knowledge and experience with Medical Device Quality Systems (ISO 13485 & 21 CFR Part 820) and Risk Management per ISO 14971
- Ability to use electronic systems to manage product Software Development Life Cycle; Including Defect Management, Risk Management, and Test Management
- Experience with Software Human Factors and Usability Engineering is a plus but not required
- Knowledge of SAAS, IAAS, and PAAS for Microsoft Azure environments is a plus but not required
- General understanding of Waterfall & Agile software development methodologies is a plus but not required
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
This job has expired.
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