Senior Quality Engineer at Repligen… · Rancho…

Senior Quality Engineer

Location: Rancho Dominguez, CA

The Senior Quality Engineer serves as a key quality representative supporting manufacturing, engineering, operations, supply chain, and customer quality activities at the Rancho Dominguez manufacturing facility. This position is responsible for ensuring products are manufactured in compliance with applicable quality standards, regulatory requirements, and company procedures while driving continuous improvement initiatives that enhance product quality, reduce risk, and improve customer satisfaction.

The Senior Quality Engineer provides technical leadership for quality investigations, CAPA activities, risk assessments, process validation, change management, supplier quality activities, and customer complaint investigations. This role partners closely with cross-functional teams to maintain a robust Quality Management System (QMS) and support business growth while maintaining compliance with ISO 9001, GMP principles, and customer requirements.

Essential Duties and Responsibilities:

• Use investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes.
• Perform FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability concerns.
• Monitor the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place.
• Prepares quality/inspection plans, procedures and instructions, and product / raw materials specifications.
• Performs testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, or test methods.

• Reviews manufacturing planning for appropriate quality requirements.
• Prepares appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures documentation contains the necessary criteria and provisions for effective inspection and testing.
• Compile and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the completion and effectiveness of corrective actions.
• Perform investigations and prepare reports for customer complaints.
• Conducts or participates in ISO audits, internal audits, and Customer audits.
• Prepare and review Quality Technical Agreements and supplier evaluation surveys.
• Support process/product improvement projects, product design reviews, products and raw materials non-conformance investigations, review and disposition.
• Perform ISO, GDP, and technical training.
• Interface at all organizational levels within the company, customers, and suppliers.
• Act as direct quality liaison with Engineering, Manufacturing, Marketing and customers.
• May serve as Lab Safety Coordinator in conjunction with the company’s Hazard Communication Program.

Travel Requirements:

• Occasional travel may be required based on business needs.

Education and/or Work Experience Requirements:

• Bachelor’s degree in Engineering or Life Science.
• 7+ years Quality Engineering and/or Manufacturing Engineering experience.
• Demonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations.
• Knowledge of Investigative / problem solving tools and scientific/technical investigations.
• Experience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data analysis.
• Good interpersonal, verbal communication and writing skills. Able to express thoughts and concepts at both technical and administrative level.
• Demonstrated ability to proficiently review technical and quality requirements, deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.).
• Good knowledge and skills in the use of advanced computer programs for word processing, spreadsheets, database and flow charts

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)
• Lead Auditor Certification
• Experience with MasterControl or comparable eQMS platforms
• Experience supporting filtration products, single-use technologies, medical devices, biologics, or pharmaceutical manufacturing
  
  

Physical Requirements:

• Ability to sit at a computer desk for an extended period of time
• Ability to work in a laboratory environment and exposure to hazardous materials
• Regularly required to stand, sit, walk, use hands and arms
• Lift/ or move up to 25 pounds