Quality Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop and review quality inspection and test plans for new product development and legacy production parts
• Contribute manufacturing and quality expertise to design reviews for product development, supplier changes, product changes and/or improvements for legacy production parts
• Coordinate review and resolution of non-conformances, liaising with internal stakeholders and suppliers to develop, implement and monitor corrective and preventative action (CAPA) plans
• Responsible for Supplier Recurrent Approvals, Source Inspections and Audits

JOB QUALIFICATIONS

• Bachelor’s Degree
• Knowledge of FDA Regulations (21 CFR 820) and ISO 13485
• Minimum of 3 years of experience in a Quality/Engineering role
• Strong knowledge of Root Cause Analysis and CAPA tools
• Knowledge of Geometric Dimensioning & Tolerance and Standard Measurement & Test Equipment
• MS Office proficiency required, 3D CAD Software is a plus
• Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, rations, and proportions to practical situations

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

Job Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES •Develop and review quality inspection and test plans for new product development and legacy production parts •Contribute manufacturing and quality expertise to design reviews for product development, supplier changes, product changes and/or improvements for legacy production parts •Coordinate review and resolution of non-conformances, liaising with internal stakeholders and suppliers to develop, implement and monitor corrective and preventative action (CAPA) plans •Responsible for Supplier Recurrent Approvals, Source Inspections and Audits JOB QUALIFICATIONS •Bachelor’s Degree •Knowledge of FDA Regulations (21 CFR 820) and ISO 13485 •Minimum of 3 years of experience in a Quality/Engineering role •Strong knowledge of Root Cause Analysis and CAPA tools •Knowledge of Geometric Dimensioning & Tolerance and Standard Measurement & Test Equipment •MS Office proficiency required, 3D CAD Software is a plus •Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, rations, and proportions to practical situations