Head of Quality Engineering & Product Surveillance

Repligen Corporation; Marlborough (MA); On-site; USD 111,000 - 156,000; Full time

Benefits offered by this job

Paid time off

Health benefits

Dental and Vision benefits

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corporation in Marlborough, MA, is seeking a Manager of Quality Engineering Product Surveillance to lead a team focused on quality investigations, CAPA, and continuous improvement within the ISO 9001 framework.

This hands-on leader partners with Engineering, Manufacturing, and Customer-facing teams to resolve product issues, drive cross-functional problem solving, coach staff, and strengthen customer confidence while achieving business results.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 7+ years of Quality Assurance and Quality Management Systems experience.
• Minimum of 3 years of leadership experience.
• Strong knowledge of ISO 9001 requirements and QMS principles.
• Demonstrated expertise in complaint handling, CAPA, root cause analysis, and CI methodologies.
• Experience with electronic quality management systems.
• Proven ability to lead teams, influence cross-functional partners, and drive results.
• Experience leading internal and external quality audits.

Responsibilities

• Lead and manage electronic complaint management system, ensuring data integrity and compliance.
• Provide day-to-day leadership for complaint handling, setting priorities and removing roadblocks.
• Lead cross-functional investigations with Quality, Manufacturing, Engineering, and Customer-facing teams to identify root causes.
• Champion corrective and preventive actions to reduce risk and prevent recurrence.
• Build partnerships with customers by communicating findings and updates on actions.
• Coach and develop team members in quality system requirements and ISO 9001 principles.
• Monitor, analyze, and report complaint metrics and KPIs for continuous improvement.
• Act as liaison between customers, Production, Engineering, and Quality teams to align outcomes.
• Balance customer needs with business objectives and quality requirements on escalations.
• Lead, develop, and retain a high-performing Quality team; deploy resources to meet demand.

Skills

Leadership

ISO 9001

CAPA

Root cause analysis

Quality management

Cross-functional collaboration

Quality investigations

Data-driven decisions

Communication

Education

Bachelor's degree in Engineering/Life Sciences

Tools

QMS

Salesforce

Job description

Repligen Corporation in Marlborough, MA, is seeking a Manager of Quality Engineering Product Surveillance to lead a team focused on quality investigations, CAPA, and continuous improvement within the ISO 9001 framework.

This hands-on leader partners with Engineering, Manufacturing, and Customer-facing teams to resolve product issues, drive cross-functional problem solving, coach staff, and strengthen customer confidence while achieving business results.