Senior Quality Assurance Engineer

2 days ago

Irvine, California, United States Masimo Full time
Job Summary

The Quality Engineer position at Masimo is a multifaceted role that requires a wide breadth of engineering knowledge. As an integral part of the product development team, quality engineers help guide and direct the team to produce quality products. The successful candidate will exhibit the following skills:

  • Excellence in working in a team environment
  • Strong engineering knowledge
  • Good understanding of quality engineering
  • Commitment to a career in quality
  • Ability to take on and overcome challenges
  • General interest in improving products and processes
Duties & Responsibilities

The Quality Engineer will be responsible for:

  • Supporting the Product Assurance goal of driving quality as a competitive advantage
  • Maintaining up-to-date knowledge of Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR), MDD 93/42 EEC and other applicable international medical device standards and regulations
  • Participating in problem-solving activities related to design, manufacture, inspection, and test, including CAPA, NCR and supplier-related issues
  • Solving identified issues through analysis, critical thought, and development of a clear set of recommendations to the team and management for resolution
  • Participating in the improvement of product and manufacturing quality and reliability through tools appropriate for the project, such as test sample size selection, test method validations, Gage R&R studies, and SPC
  • Contributing as part of multi-departmental teams in product and process risk analysis and risk management activities, including the development of product and process FEMA and Risk Analysis reports
  • Ensuring robust application of the quality system by supporting the entire Quality Management System including the CAPA, NCR, customer feedback activities, and product failure analysis
  • Developing and maintaining Design History Files (DHF) for products
  • Performing other duties or special projects as requested
Minimum & Preferred Qualifications and Experience

The ideal candidate will have:

  • 3 years of Quality Engineering/Quality Assurance experience
  • 2 years' experience in a medical device design, development, and manufacturing environment
  • Direct experience with ISO 13485 and FDA QSRs
  • Direct experience in Test protocol development and execution in support of new product development and/or failure analysis
  • Hands-on experience implementing and using statistical methods throughout various aspects of product realization, including use of PFMEA, DFMEA, DOE and GR&R methodologies
  • Strong communication, documentation, problem-solving and teamwork skills
  • Ability to occasionally travel domestically and internationally
  • Proficiency with Microsoft Office applications
  • Prior experience with PLM, MMS, ERP systems
Education

A B.S. in Electrical Engineering, Biomedical/Biomechanical Engineering, or a related science/engineering discipline is required. An M.S. in a related Engineering or science discipline is a plus.

Compensation

The anticipated range for this position is $67,000 - $91,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical Requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

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