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Quality Engineer I

Position Description/Responsibilities:

Entry-level to intermediate Quality Engineer responsible for providing technical support to manufacturing and quality systems under established procedures and moderate supervision. Applies basic to intermediate knowledge in Process and Quality Engineering to support the implementation, coordination, and follow-up of manufacturing methods and procedures.

Supports the delivery of high-quality products by assisting in the identification, investigation, and resolution of quality-related issues. Participates in-process analysis and improvement activities to enhance operational efficiency and product quality.

Position Authority:

This position has the authority to develop and analyze quality data and reports to support evaluation of compliance with internal and external standards. Provides recommendations for quality improvements and supports the implementation of corrective and preventive actions under guidance. Works collaboratively with cross-functional teams to support product and process quality, escalating issues as needed.

Essential Functions:

• Perform quality support activities for assigned customer accounts and production areas under moderate supervision, ensuring compliance with procedures and timely issue escalation.
• Support quality and manufacturing activities in compliance with GMP, SOPs, FDA and ISO requirements.
• Develop, review and maintain quality documentation (control plans, FMEAs, specifications).
• Execute reviewing / approval of any documentation created / updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
• Support validation activities (IQ/OQ/PQ) with approved protocols for sustaining projects.
• Investigate nonconformances, customer complaints and participate in CAPA activities under guidance.
• Support internal and external audits by preparing documentation and data.
• Apply basic statistical and problem solving tools to support quality investigations.
• Support manufacturing and quality personnel with training on procedures and documentation.
• Support Operational Excellence (OPEX) projects (e.g., Lean, Six Sigma, Continuous Improvement) based on business needs, contributing to execution, data collection, and implementation of improvements.
• Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.

Knowledge and Education:

• Bachelor’s degree in Engineering or related discipline.
• Bilingual English/Spanish – Intermediate English level, reading and listening comprehension, writing and oral expression.
• Basic knowledge and application of statistical techniques (basic descriptive statistics).
• Basic knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software is a plus.

Job Experience:

• 0-3 years of experience in quality assurance, engineering, or a related role.
• Experience implementing continuous improvement programs in manufacturing environment.

Skills and Competencies:

• Good interpersonal skills and the ability to communicate orally and in writing.
• Self-motivated.
• Organized and able to manage multiple tasks and priorities.
• Must be able to work and effectively communicate with others.
• Highest ethical standards and professional integrity.
• Able to work with minimum supervision.
• Teamwork oriented.
• Decision making: Able to make routine decisions with guidance and escalate complex issues appropriately.
• Proactive
• Discipline
• Customer oriented
• Team player
• Diligent
• Retentive
• Good learner
• Hands-on, collaborative, decisive.
• Must be flexible and adapt to changing environments and priorities.
• Problem Solving: Basic understanding of problem-solving methodology.
• Metrology: Basic knowledge of measurement and error theory and measuring instruments and equipment.

Physical Requirements:

• Regularly required to stand, walk, stop, kneel, crouch, and use hands to finger, handle or free objects.
• Light physical activity performing non-strenuous, day-to-day activities of a primarily administrative nature.
• Moderate lifting (20 lbs.), carrying (10 lbs.), bending, and prolonged sitting.

Equipment Used:

• Standard office equipment, monitor, computer, printer. 
• Software tools: Microsoft office, Minitab and others requires for function.
• Company tools: ERP, Data collection, document change control.