Senior Quality Engineer

RepliGen Corporation; California; On-site; USD 115,000 - 155,000; Full time

Job summary

RepliGen Corporation in Rancho Dominguez, CA seeks a Senior Quality Engineer to partner across Manufacturing, Engineering, Operations, Supply Chain, and R&D to ensure high-quality biologics products. You will lead investigations, CAPA, and QA initiatives from concept through implementation.

The role emphasizes data-driven decisions, cross-functional collaboration, and ongoing quality improvements. It requires strong technical communication and the ability to influence outcomes in a regulated

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 7+ years of Quality/Manufacturing Engineering in regulated environment.
• Working knowledge of quality systems and regulatory requirements.
• Experience with investigative methodologies, RCA, CAPA, auditing, and statistical data analysis.
• Strong data analysis and communication across technical audiences.
• Proficiency with Microsoft Office; familiarity with eQMS like MasterControl preferred.
• Experience with regulated industries (biologics, pharma) preferred.
• CQE/CQA or Lead Auditor certifications are a plus.
• Ability to work in office and manufacturing/lab environments, incl. lifting up to 25 lbs.

Responsibilities

• Lead investigations and root-cause analysis for manufacturing and R&D projects.
• Perform FMEA, RCA, Gauge R&R, and process control activities.
• Monitor metrology/calibration to meet quality objectives.
• Prepare quality and inspection plans and product specs.
• Conduct testing, qualifications, data analysis; suggest improvements.
• Review manufacturing plans for quality requirements and risk.
• Document critical QC points across processes.
• Lead CAPA and track corrective actions to closure.
• Prepare reports for customer complaints and ensure timely resolution.
• Assist audits (ISO, internal, customer) and drive improvement.
• Prepare quality agreements and supplier evaluations.
• Support process/Product improvement projects and design reviews.
• Deliver ISO, GDP training to promote quality awareness.
• Build relationships with customers and suppliers; liaison with Eng/Manufacturing.
• May serve as Lab Safety Coordinator.

Skills

Root cause analysis

CAPA

Process validation

Statistical data analysis

FMEA

Auditing

Education

Bachelor’s degree in Engineering or related field

ASQ CQE / CQA certification (plus)

Tools

MasterControl (eQMS)

Job description

The Senior Quality Engineer is a key member of the Rancho Dominguez team, serving as a trusted quality partner across Manufacturing, Engineering, Operations, Supply Chain, and R&D. In this role, you will help ensure the delivery of high-quality products while driving initiatives that improve performance, reduce risk, and enhance the customer experience.

This position combines technical problem-solving, data-driven decision making, and cross-functional collaboration. You will lead investigations, support customer complaint resolution, manage quality improvement initiatives, and contribute to new product introductions from concept through implementation. As a senior individual contributor, you’ll have the opportunity to influence outcomes, build strong partnerships across the organization, and help shape a culture focused on quality, innovation, and continuous improvement.

This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.

Responsibilities

• Use investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes, driving effective resolution and supporting long-term quality improvements.
• Perform FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve quality and reliability concerns while proactively preventing future issues.
• Monitor metrology and calibration activities to ensure quality objectives are met and that effective procedures and work instructions are in place to support operational excellence.
• Prepare quality and inspection plans, procedures, instructions, and product and raw material specifications that support consistent product quality and manufacturing performance.
• Perform testing, validation, equipment qualifications, and data analysis. Recommend improvements to equipment, products, and test methods based on technical findings and business needs.
• Review manufacturing planning to ensure appropriate quality requirements are incorporated and potential risks are identified early.
• Prepare documentation for critical quality control points throughout manufacturing processes, ensuring clear criteria and requirements for effective inspection and testing.
• Compile and analyze data related to quality and manufacturing issues, initiate CAPA activities, and monitor the completion and effectiveness of corrective actions to drive sustained improvements.
• Perform investigations and prepare reports for customer complaints, helping ensure timely resolution and a positive customer experience.
• Conduct or participate in ISO, internal, and customer audits, contributing to a culture of quality, accountability, and continuous improvement.
• Prepare and review Quality Technical Agreements and supplier evaluation surveys, fostering strong quality partnerships with suppliers and external stakeholders.
• Support process and product improvement projects, product design reviews, and nonconformance investigations, helping drive quality improvements across the product lifecycle.
• Perform ISO, GDP, and technical training to promote quality awareness, knowledge sharing, and best practices across the organization.
• Build and maintain effective working relationships at all organizational levels, including customers and suppliers, to support quality and business objectives.
• Serve as a trusted quality liaison with Engineering, Manufacturing, Marketing, and customers, helping align priorities and drive successful outcomes.
• May serve as Lab Safety Coordinator in conjunction with the company’s Hazard Communication Program.
• Demonstrated ability to leverage AI-enabled and digital tools to improve efficiency, enhance decision-making, and support continuous improvement initiatives.

Education & Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 7+ years of Quality Engineering and/or Manufacturing Engineering experience within a regulated manufacturing environment.
• Working knowledge of quality systems and regulatory requirements.
• Experience with investigative and problem-solving methodologies, root cause analysis, CAPA, quality planning, auditing, and statistical data analysis.
• Strong technical aptitude with the ability to evaluate quality requirements, analyze data, and interpret technical information.
• Experience performing scientific and technical investigations, validation activities, and process improvement initiatives.
• Excellent verbal, written, and interpersonal communication skills, with the ability to effectively communicate across technical and non-technical audiences.
• Proficiency with Microsoft Office applications and other computer-based tools, including spreadsheets, databases, and flowcharting software.
• Experience with MasterControl or similar electronic Quality Management Systems (eQMS) is preferred.
• Experience supporting filtration products, single-use technologies, medical devices, biologics, pharmaceutical manufacturing, or other regulated industries is preferred.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Lead Auditor certification, or related quality certifications are a plus.
• Ability to work in both office and manufacturing/laboratory environments, including periods of sitting, standing, walking, and lifting up to 25 pounds.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $115,000-$155,000. Compensation decisions are dependent on several factors including, but not limited to an individual’s ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.