Onsite QA Engineer — Advanced Manufacturing & CAPA Lead

Actalent; San Diego (CA); On-site; USD 78,000 - 90,000; Full time

Job summary

Actalent is seeking a Quality Assurance Engineer to support quality activities in a fast-paced, advanced manufacturing environment. The role focuses on root cause analysis, CAPA, and collaboration with manufacturing, engineering, and quality teams to improve product quality and regulatory compliance.

You will be involved in audits, data analysis, and hands-on work on the production floor and in cleanroom areas, with direct interaction on quality investigations and corrective actions as needed.

Qualifications

• Experience in quality engineering within a manufacturing environment.
• Experience performing root cause investigations and corrective actions (CAPA).
• Strong analytical and problem-solving abilities applied to manufacturing quality issues.
• Ability to communicate technical information across levels and document quality data clearly.
• Eligibility to work in an ITAR-regulated environment.

Responsibilities

• Support quality engineering activities to ensure products meet internal and customer quality standards.
• Investigate quality issues and drive timely, effective resolution.
• Conduct root cause analyses (5 Why, RCA) and implement corrective actions.
• Review production processes and analyze quality data to identify trends and improvement opportunities.
• Partner with manufacturing, engineering, and quality teams to improve product quality and compliance.
• Support customer complaint investigations and communicate findings clearly.
• Create and maintain quality documentation and records for the quality system.
• Participate in internal and external quality audits and ISO 9001 activities.
• Review engineering drawings and specifications to ensure quality requirements are defined and met.
• Identify quality risks on the floor and assist with process changes.
• Engage with customers on quality issues and corrective actions when required.

Skills

Root cause analysis

CAPA

5 Why Analysis

Quality data analysis

Cross-functional collaboration

Documentation

Problem solving

Communication

ITAR compliance

Education

Bachelors degree in Mechanical or Chemical Engineering

Job description

Actalent is seeking a Quality Assurance Engineer to support quality activities in a fast-paced, advanced manufacturing environment. The role focuses on root cause analysis, CAPA, and collaboration with manufacturing, engineering, and quality teams to improve product quality and regulatory compliance.

You will be involved in audits, data analysis, and hands-on work on the production floor and in cleanroom areas, with direct interaction on quality investigations and corrective actions as needed.