Staff Quality Engineer

About the role

Confluent Medical Technologies is seeking a Staff Quality Engineer to join our Laguna Niguel, CA team. The ideal candidate will bring a unique blend of technical expertise and problem-solving skills to our dynamic environment.

Responsibilities

• Ensure compliance to customer, risk management, quality and design control requirements in design and development projects.
• Help ensure successful transfer of the design to manufacturing.
• Work on problems and projects of moderate to complex scope, requiring a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills.
• Participate in decisions on scope of work, selection of materials/equipment/test methodology and length of tasks.
• Participate in decisions on design changes to meet revised specifications.
• Provide and develop solutions to problems of limited to moderate scope.

Qualifications

• BS in a related engineering discipline with 5 years of related experience working in Quality in a medical device environment.
• MS in a related engineering discipline with 4 years of related experience working in Quality in a medical device environment.
• 5+ years experience in Medical Device Product Development.
• 5+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements.
• Demonstrated knowledge of and practical application of ISO 14971 requirements.
• Strong statistical data analysis skills using Minitab is a must, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments, variable and attribute sampling plan applications, design of experiments (DOE) and response surface models.
• Certification in ISO 13485 preferred.

Skills

• Statistical data analysis skills using Minitab.
• Design of Experiments (DOE).
• Response Surface Models.
• Process Capability Analysis.
• Hypothesis Testing.
• Tolerance Interval Analysis.
• ANOVA.
• Sample Size Requirements.
• Variable and Attribute Sampling Plan Applications.

Benefits

Confluent Medical Technologies offers very competitive compensation and benefits, including:

• Comprehensive health insurance plans.
• Paid time off and holidays.
• Flexible work schedule.
• Professional development opportunities.
• Employee wellness programs.

Pay

Compensation is commensurate with experience and qualifications.

Schedule

Full-time position.

Contact

If you're interested in joining our team, please submit your resume and cover letter. No phone calls, faxes, or emails, please. We look forward to hearing from you!