manufacturing quality engineer ii

$73,840 - $92,040/Yr

Randstad - San Diego, CA

Full-time - Mid Level

San Diego, CA

Administrative and Support Services

About the position

The Manufacturing Quality Engineer II position is responsible for overseeing manufacturing and product quality activities. This role involves collaboration with the Manufacturing and Process Engineering teams to support ongoing production, drive continuous improvement, and expand manufacturing capacity. It is a contract role lasting 5 months with the possibility of extension.

Responsibilities

• Offer continuous quality engineering support across the entire product life cycle.
• Support manufacturing functions with validation planning and transfer activities.
• Ensure non-conformances, CAPA records, investigations, and corrective actions are adequate.
• Gain familiarity with relevant technology for effective participation in technical discussions and risk-based decision-making.
• Review equipment onboarding, calibration, and maintenance tickets; identify potential GMP compliance gaps.
• Review change requests, notices, and approvals for compliance with requirements in relevant WIs/Procedures.
• Develop and execute strategies to close gaps efficiently and in compliance.
• Coordinate issue resolution using a risk-based approach.
• Ensure manufacturing processes comply with FDA and ISO standards.
• Analyze and report quality data to improve product and processes; provide data-driven recommendations.
• Update management on responsibilities, progress, and timely escalation of issues.

Requirements

• 2 to 4 years of applied experience in the quality assurance field in a regulated environment.
• Applied experience in meeting and ing quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) desired.
• Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
• Quality System tools (e.g., electronic CAPA/NC, Change Management systems).
• Bachelor's degree in an engineering or scientific discipline.

Benefits

• Health insurance
• 401K contribution
• Incentive and recognition program