Quality Engineering Manager: Product Surveillance

RepliGen Corporation; West Village (MA); On-site; USD 111,000 - 156,000; Full time

Benefits offered by this job

Bonus eligibility

Equity potential

Comprehensive benefits

Job summary

Repligen Corporation seeks a Manager of Quality Engineering Product Surveillance to lead a team responsible for quality investigations, CAPA, and continuous improvement within our ISO 9001 framework. You will partner with Engineering, Manufacturing, Quality, and Customer-facing teams to resolve complex quality issues and strengthen customer confidence.

The role emphasizes developing people, data-driven decisions, and collaboration across functions to deliver product quality and business results.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 7+ years of Quality Assurance and QMS experience.
• Strong knowledge of ISO 9001 requirements and QMS principles.
• Experience leading complaint handling, CAPA, root cause analysis, and continuous improvement.

Responsibilities

• Lead and maintain the electronic complaint management system, ensuring data integrity and compliance.
• Provide day-to-day leadership for complaint handling, prioritization, escalations, and timely execution.
• Lead complex cross-functional investigations to identify root causes and drive corrective actions.
• Champion proactive problem-solving to reduce risk and recurrence of failures.
• Develop and coach team members on quality system requirements and customer expectations.

Skills

Quality systems

Leadership

CAPA

Root cause analysis

Cross-functional collaboration

Quality investigations

Problem solving

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Salesforce

Electronic quality management system (eQMS)

Job description

Repligen Corporation seeks a Manager of Quality Engineering Product Surveillance to lead a team responsible for quality investigations, CAPA, and continuous improvement within our ISO 9001 framework. You will partner with Engineering, Manufacturing, Quality, and Customer-facing teams to resolve complex quality issues and strengthen customer confidence.

The role emphasizes developing people, data-driven decisions, and collaboration across functions to deliver product quality and business results.