Required Skills & Experience
Bilingual English & Spanish Bachelor’s degree with 3–5 years of Quality or Quality Engineering experience, or an applicable Quality Engineering certification. 3–5 years of experience with corrective actions and nonconformances, including investigation and resolution. Minimum 3 years of experience with New Product Introduction (NPI) and a strong understanding of the NPI lifecycle. 3–5 years of experience leading or participating in FMEAs.
Hands-on experience with root-cause investigation tools such as:
Fishbone / Ishikawa diagrams 5 Whys Other structured root-cause analysis methodologies Experience working with SCARs, NCMRs, and quality investigations. Familiarity with IQ/OQ/PQ and validation activities. Intermediate proficiency with Microsoft Office, particularly Excel. Experience working within ERP and electronic Quality Management Systems (eQMS). Ability to work effectively across Quality, Engineering, Manufacturing, and QC functions
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
Job Description
The Quality Engineer supports the development, implementation, and continuous improvement of products and manufacturing processes within a regulated environment. This individual will work cross-functionally with Quality, Engineering, Manufacturing, and QC teams to ensure product quality, safety, reliability, and effectiveness.
Key Responsibilities
Help mitigate and eliminate quality fade as product and process changes are implemented. Review, revise, and create quality documentation, including SQS, SQRs, and Work Instructions. Participate in and support SCAR, NCMR, and ICAR investigations. Train and mentor Quality Control personnel on quality processes and procedures. Partner with Engineering and Manufacturing to develop and maintain Product Development Quality Matrices. Support IQ, OQ, and PQ activities for new and existing products and manufacturing processes. Create, manage, and analyze Manufacturing and Quality KPIs, including identifying trends and areas for improvement. Contribute to risk assessments and risk analysis. Apply structured root-cause analysis and problem-solving methodologies to quality issues. Support continuous improvement initiatives across manufacturing and quality processes.