Quality Manager, ISO 9001 — Global Quality Leader

Harvardbioscience; Saint Paul (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Harvard Bioscience in New Brighton, MN seeks a Quality Manager to drive the Global Quality Plan and align processes with data across production, development, and post-market teams.

You will lead and mentor the quality team, manage the Quality Management System, and respond to regulatory changes and external audits. The role emphasizes cross-functional collaboration and CAPA governance in a fast-paced environment.

Qualifications

• Strong leadership and organizational skills.
• Knowledge of manufacturing and process development principles.
• Experience in quality systems and cross-functional collaboration.

Responsibilities

• Lead and expand quality culture; mentor quality team leads.
• Manage Quality Management System architecture to meet corporate needs.
• Track regulatory changes and recommend system changes.
• Lead CAPA review board and risk assessments.
• Plan and execute internal audits and respond to external requests.
• Support validation of manufacturing processes and change controls.
• Assist design verification and design validation activities.

Skills

Quality leadership

ISO 9001

Regulatory knowledge

CAPA processes

Cross-functional teamwork

Education

Engineering degree

Job description

Harvard Bioscience in New Brighton, MN seeks a Quality Manager to drive the Global Quality Plan and align processes with data across production, development, and post-market teams.

You will lead and mentor the quality team, manage the Quality Management System, and respond to regulatory changes and external audits. The role emphasizes cross-functional collaboration and CAPA governance in a fast-paced environment.