Regional Quality Manager

Overview

Onsite/Travel Requirements

* The person in this role will ideally be located in New Jersey or Minnesota and can sit fully remote
* Onsite requirements are one week per month at one of their facilities

Position Summary

The Regional Quality Manager is responsible for leading and maintaining quality systems and performance across multiple sites within an assigned region. This role ensures compliance with applicable regulatory, customer, and internal requirements while driving continuous improvement, risk reduction, and a strong quality culture. The position partners closely with Operations, Engineering, Regulatory, Supply Chain, and other cross-functional teams to support business objectives and product integrity.  This position will also collaborate heavily with other quality professionals within the organization to identify global risks and opportunities.

Key Responsibilities:

Quality Management & Compliance

• Oversee regional implementation and effectiveness of the Quality Management System (QMS) in alignment with corporate standards and applicable regulations (e.g., ISO, FDA, GMP, UL, CE, customer requirements).
• Ensure consistent application of quality policies, procedures, and work instructions across all sites in the region.
• Monitor regulatory and standards changes and assess regional impact.

Audits & Inspections

• Lead preparation and execution of internal, external, customer, and regulatory audits.
• Support site teams during customer inspections and act as a regional point of contact for quality-related findings.
• Ensure timely and effective responses to audit observations, including root cause analysis and corrective actions.

Corrective & Preventive Actions (CAPA)

• Oversee regional CAPA processes to ensure effective investigation, root cause determination, and sustainable corrective actions.
• Track CAPA trends and performance metrics; escalate risks as needed.

Performance & Continuous Improvement

• Define, monitor, and report regional quality KPIs (e.g., nonconformances, complaints, audit findings, cost of poor quality).
• Drive continuous improvement initiatives using risk-based and data-driven approaches.
• Share best practices and lessons learned across sites to improve consistency and performance.

Leadership & Collaboration

• Provide leadership, coaching, and mentoring to site quality teams.
• Partner with Operations, Engineering, Regulatory, Supply Chain, Finance, and PMO to support new product introductions, process changes, and issue resolution.
• Foster a strong quality mindset and accountability throughout the region.

Customer & Stakeholder Support

• Support resolution of significant customer quality issues and complaints.
• Represent the region in corporate quality forums and management reviews.

Qualifications

• 7+ years of progressive experience in quality management within a regulated or manufacturing environment.
• Experience managing quality systems across multiple sites or locations.
• Strong knowledge of QMS, audits, CAPA, and continuous improvement methodologies.
• Demonstrated leadership and ability to influence cross-functional teams.
• Familiarity with digital QMS tools and data-driven quality reporting.

Skills & Competencies

• Strategic and risk-based thinking
• Strong communication and stakeholder management
• Problem-solving and root cause analysis
• Change management and coaching
• Ability to travel within the assigned region (as required)

The target hiring compensation range for this role is $90k – $110k+ bonus. Compensation is based on several factors including, but not limited to education, relevant work experience, relevant certifications, and location.