Quality Manager ISO9001

Harvard Bioscience•St Paul, MN

9d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.
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.
Supports validation of manufacturing processes.
Supports manufacturing change control projects.
Reviews exception proposals as part of risk assessment.
Supports project, verification, and design validation planning.
Supports design change control projects.