Quality Engineer

Confluent Medical Technologies; Laguna Niguel (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading medical device firm located in Laguna Niguel, California, is seeking a Quality Engineer with a strong background in risk management and statistical analysis. The role involves developing and maintaining risk management files, providing guidance on statistical topics, and ensuring compliance with industry regulations like FDA and ISO standards. Ideal applicants should have a BS or MS in engineering and substantial experience in medical device product development.

Qualifications

• 5 years of experience in Quality in a medical device environment or equivalent.
• Experience with FDA, ISO 13485, and EU MDR Design Control requirements.
• Strong statistical data analysis skills.

Responsibilities

• Lead generation and maintenance of risk management files.
• Provide guidance on statistical analysis topics.
• Participate in design changes to meet revised specifications.

Skills

Statistical data analysis

Knowledge of FDA regulations

Design Control experience

Risk Management

Critical thinking

Education

BS in a related engineering discipline

MS in a related engineering discipline

Tools

Minitab

Job description

is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering and manufacturing. Our primary capabilities include: Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers. and design control requirements is Work on problems and projects of moderate to complex scope where analysis of situation or data requires 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. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Work requires a broad knowledge of precedents, principles and practices in the product development and design assurance areas. Familiarity with regulatory guidance documents and standards is required. Responsible for taking the lead in generating and maintaining risk management files supporting product development projects, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents based on translation of customer product requirements.Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis and ANOVA. with Customer as needed on Design and Development Responsibilities, Quality Issues and **EDUCATION and/or EXPERIENCE:** BS in a related engineering discipline; and 5 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience MS in a related engineering discipline and 4 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience 5+ years experience in Medical Device Product Development5+ 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 compensation and benefits and is proud to have a distinguished reputation throughout the medical device industry around the world! We welcome eager and ambitious team players to apply.