Bilingual Quality Engineer

Job Description

The Quality Engineer supports the development and improvement of products and processes by applying associated quality methods. Working on cross functional teams in a regulated environment to ensure quality, safety, reliability, and efficacy of products and processes

Key Responsibilities:

Help to Mitigate and Eliminate Quality Fade as changes are implemented

Daily Review, Revise, and Create Documents such as SQS, SQRs,and Work Instructions

Contribute and collaborate with SCAR, NCMRs, and ICAR investigations

Train and mentor QC personnel

Collaborating with Engineering and Manufacturing in Product Development Quality Matrices

Support IQ, OQ, PQ activities on new and existing products

Create and Manage Manufacturing and Quality KPI Data and Trends

Contribute to Risk Assessment and Analysis

Skills and Requirements

Bachelor's Degree with 3-5 years in Quality or Quality Engineering Certification

3-5 years of experience with corrective actions and non conformances 3 years minimum experience with NPI and basics of NPI

3-5 years of experience leading and or participating in FMEA

Experience utilizing investigational tools such as fishbone, 5whys..etc

Intermediate in Microsoft office, ERP, and eQMS, excel

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].