Quality Assurance Systems Manager

Quality Assurance Systems Manager

About This Opportunity

We're seeking an experienced Quality Assurance Systems Manager to lead quality operations at our manufacturing facility. You'll own our change control and document management processes, oversee quality investigations and corrective actions, and ensure regulatory compliance in a GMP-regulated environment. This is a leadership role where you'll have direct impact on quality culture and operational excellence.

What You'll Do

Quality Systems Leadership

• Serve as site administrator for change control and document control systems
• Develop and implement quality system policies and standard operating procedures
• Review and approve investigations, CAPAs, and GMP documentation to ensure timely, compliant closure
• Manage quality records and production material specifications
• Act as backup for product disposition and regulatory compliance decisions

Team & Stakeholder Management

• Supervise and mentor a team of 7-8 quality control professionals
• Coordinate Site Quality Review Team meetings and prepare reports
• Support internal and external audits, including corrective action execution
• Collaborate with cross-functional teams on continuous improvement initiatives
• Provide training and guidance on quality system requirements across the site

Reporting & Analytics

• Prepare quality metrics and system performance reports for leadership review
• Present change control system status updates to management forums
• Monitor and assess quality system effectiveness through data analysis
• Document and communicate all quality activities and findings

What We're Looking For

Required

• Bachelor's degree in science, engineering, or related field (or equivalent professional experience)
• 8+ years of quality assurance experience in a GMP-regulated environment
• Proven expertise in change control, document control, investigations, and CAPA processes
• Proficiency with quality management systems (TrackWise, Documentum, SAP, or similar)
• Knowledge of GMP and ISO regulatory requirements
• Demonstrated supervisory experience and cross-functional leadership skills
• Excellent written and verbal communication abilities
• Detail-oriented and organized with strong decision-making skills

Preferred

• Medical device or pharmaceutical manufacturing background
• MDR and EU regulatory compliance experience
• ASQ auditing certification or related quality credentials
• Lean or Six Sigma certification
• Experience with production material release processes

Why Join Us

• Competitive salary range: $90,000–$115,000
• Performance bonus: 10% annually
• Comprehensive benefits package with 100% employer-paid premiums for medical, dental, and vision coverage
• 401(k) with 100% match on first 4% of contributions and 7% safe harbor plan
• Tuition reimbursement and professional development support
• Generous PTO and company-observed holidays
• On-site position offering stability and community