Quality Manager ISO9001

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

ABOUT HARVARD BIOSCIENCE

Harvard Bioscience is a leading global developer, manufacturer and seller of technologies, products and services that enable fundamental research, discovery, and pre-clinical testing for drug development. Our customers range from renowned academic institutions and government laboratories, to the world's leading pharmaceutical, biotechnology and clinical research organizations.

POSITION SUMMARY

Harvard Bioscience is looking for a Quality Manager for our New Brighton office. This role is responsible for executing the Global Quality Plan, driving cultural changes toward Quality processes, and collaborating with production, product development, sales/marketing, and post-market teams to ensure connection with processes and data.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Leadership:

• Support and expand the culture to provide high quality products to customers.
• Provide mentorship to quality team and department leads.
• Cultivate collaborative culture across the organization.
• Manage the Quality Management System architecture to meet corporate needs.
• Reviews Quality System operation and identifies improvements.
• Plans and leads improvement projects.

Quality:

• Leads execution of the Global Quality Plan in Holliston.
• Tracks regulatory changes and makes recommendations for system changes.
• Leads the CAPA review board, including field risk assessment.
• Plans and executes Internal Audit schedule.
• Responds to external information requests (customers, audits).
• Provides perspective and experience for information management procedures and tools.

Operations:

• Supports validation of manufacturing processes.
• Supports manufacturing change control projects.
• Reviews exception proposals as part of risk assessment.

Design:

• Supports project, verification, and design validation planning.
• Supports design change control projects.

SKILLS AND ABILITIES REQUIRED

• Strong organization, communication, and leadership skills.
• Knowledge of relevant manufacturing and process development principles and practices.
• Project management skills, ability to plan, and perform against plan.
• Interpersonal and leadership skills with the ability to establish rapport with cross functional team members to create high performance teams.
• Confidence to provide quality staff direction and assignments consistent with department objectives and priorities.
• Ability to review the manufacturing processes, design verification plans and reports, and process validation/qualification protocols and reports.
• Full understanding of ISO 9001:2015 Required.
• Experience with ISO 13485:2016, ISO 14971:2019, IEC 62366-2:2015 or other regulations a plus.
• Willing to share knowledge and teach others about processes.
• Knowledge of the full product lifecycle (Launch/Maintain/Obsolete).
• Ability to work effectively in a cross-functional team environment.
• Strong analytical ability with active listening skills.
• Ability to interpret and articulate regulatory requirements.
• Ability to lead by example.

EDUCATIONAL REQUIREMENTS AND/OR EQUIVALENT

4-year engineering degree with 5+ years relevant experience and 2+ years of management experience preferred.

AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER/VETERAN/DISABILITY

FLSA: Exempt

ADA DISCLAIMER

In developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis.