Quality Manager
$105,000–$135,000 year
On-siteSaint Paul, Minnesota, United States
Job Summary
Execute the Global Quality Plan in Holliston, lead the CAPA review board including field risk assessment, and manage the Quality Management System architecture. Track regulatory changes to recommend system updates, plan internal audits, and respond to external information requests from customers and auditors. Support manufacturing change control, validate processes, and review exception proposals as part of risk assessment. Provide mentorship to the quality team and department leads while cultivating a collaborative culture across production, product development, and sales. Interpret regulatory requirements and lead by example to drive cultural changes toward quality processes.
Required Qualifications
- 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
- 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
- 4-year engineering degree
- 5+ years relevant experience
- 2+ years of management experience
Desired Qualifications
- Experience with ISO 13485:2016, ISO 14971:2019, IEC 62366-2:2015 or other regulations a plus
- Willingness to share knowledge and teach others about processes
- Knowledge of the full product lifecycle (Launch/Maintain/Obsolete)
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