Thermo Fisher Scientific

Software Quality Compliance Engineer

Thermo Fisher Scientific

180 Oyster Point Blvd, South San Francisco, CA 94080, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

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.

Where is this job?
This job is located at 180 Oyster Point Blvd, South San Francisco, CA 94080, USA
Job Qualifications
  • 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

Required Skills
  • Time Management Skills

  • Project planning skills

  • Continuous improvement skills

  • Software Hazard Analysis

Soft Skills
  • Verbal communication

  • Driven and self-motivated

  • written communication

  • Problem Solving Skills

  • Flexibility/Adaptability

  • Detail Oriented and Organized

  • multitasker

Compensation

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.

Additional Information
Thermo Fisher Scientific is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMay 20th, 2021
Apply BeforeJune 21st, 2025
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About Thermo Fisher Scientific

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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