Quality Process Manager

Responsibilities

• Provide leadership oversight to customer audits, including preparation, execution, reporting, and closure of audit findings.
• Ensure sustained inspection of readiness and successful outcomes with customers.
• Provide leadership oversight the internal audit program, including auditor selection, training, audit scheduling, execution, and driving timely and effective corrective actions to strengthen the QMS.
• Develop, maintain, and continuously improve a robust Quality Management System compliant with ISO 13485 and applicable global regulations.
• Lead CAPA facilitators and ensure effective management of customer complaints and internal CAPAs, including root cause analysis, corrective/preventive actions, effectiveness checks, and trend analysis.
• Sustain and continue to develop QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability and continuous improvement.
• Conduct process and product audits to identify gaps and drive continuous improvement initiatives using Lean and risk-based methodologies.
• Provide leadership as a key quality representative to customers, ensuring alignment with customer expectations.
• Complete all customer supplier audits, NAFTA, & Canadian export documentation.
• Represent Quality on the Supplier Qualification Team & supplier performance reviews, ensure that Approved Supplier List (ASL), and supplier audits meets standards.
• Partner with Quality, Operations, Engineering, and other functions to implement QMS improvements that enhance efficiency, compliance, and product quality.
• Implement, maintain, and optimize QMS records, ensuring system effectiveness, data integrity, and user adoption.
• Support preparation and presentation of Management Review inputs, ensuring clear visibility to QMS performance, risks, and improvement opportunities.

Qualifications

• Bachelor's degree or 4 years of equivalent work experience
• 2 years of experience managing Quality Management Systems
• Experience or understanding of ISO 13485
• Ability to prioritize work and manage multiple tasks when needed
• Consistently produce work that meets the customer's requirements
• Project management skills
• Past quality assurance experience in a manufacturing environment strongly preferred
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint)
• Clear and effective verbal and written communication skills