
Software Quality Compliance Engineer
Provides Quality Management System (QMS) software development and validation guidance/support. Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards. Provides Regulatory and International Standards guidance/support. Facilitates software risk management activities using Risk Assessment Process, as applicable. Reviews and approves product software specification documentation for new products and for QMS systems. Ensures design changes are captured and follow the design change control process. Identifies opportunities for continuous improvement of the Quality Systems, including the design control, risk management, document generation, and design testing processes. Participates on team projects and assignments, facilitating or leading sub-teams as necessary. Use of risk management tools to evaluate impact of change.
Minimum of 5 years direct Quality Engineering experience with expertise in software Design Control for medical device industries
Working knowledge of EN ISO 14971, especially Software Hazard Analysis
Working knowledge of Electronic records/signature compliance (21 CFR Part 11)
PMP certification or similar is a plus
Time Management Skills
Project planning skills
Continuous improvement skills
Software Hazard Analysis
Verbal communication
Driven and self-motivated
written communication
Problem Solving Skills
Flexibility/Adaptability
Detail Oriented and Organized
multitasker
According to JobzMall, the average salary range for a Software Quality Compliance Engineer in 180 Oyster Point Blvd, South San Francisco, CA 94080, USA is $90,000 - $125,000 per year. This range is based on salaries reported by JobzMall users and includes base salary, bonus, and other compensation.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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