Quality Engineer II

Responsibilities

• Communicate with suppliers to resolve quality issues, manage nonconformities, and support supplier audits
• Support production quality problem-solving in cooperation with production and manufacturing engineers
• Interface with design teams to resolve quality issues arising during production
• Manage incoming inspection activities, including inspection criteria and issue resolution
• Plan and perform internal audits to ensure compliance with quality systems and procedures
• Participate in the creation and review of User Requirement Specifications (URS)
• Perform gate checks in accordance with NPI SOPs to ensure quality deliverables meet requirements
• Ensure document control and maintenance of Design History Files (DHF) and Device Master Records (DMR)
• Support FMEA activities in NPI projects to identify and eliminate quality risks
• Review and sign off on Verification & Validation documentation and Traceability Matrices

Requirements

• Bachelor’s degree in Engineering, Quality, or a related technical field
• 5+ years of quality engineering experience in manufacturing or regulated environments (e.g., medical devices, automotive, or electronics)
• Strong knowledge of quality tools such as FMEA, root cause analysis, and CAPA
• Familiarity with audits, document control, and quality management systems
• Strong communication skills and the ability to collaborate across functions and with external suppliers
• Detail-oriented, analytical, and proactive problem-solving mindset

Benefits

• Competitive salary range
• Paid time off
• Health, dental, and vision insurance
• Retirement benefits
• Flexible spending accounts
• Eligibility for variable cash programs (bonus or commission) and equity

About the Company

Repligen is a leader in bioprocessing, dedicated to inspiring advances in the production of biologic drugs that improve human health worldwide. We deliver innovative technologies and solutions that help set new standards in bioprocessing efficiency and cost-effectiveness.