Quality Systems Lead

Job title: Quality Systems Lead

About the Role This role is responsible for leading quality-related initiatives, including MQRB, CAPA and Regulatory Audits, ensuring regulatory readiness, and serving as the Backroom Manager during audits and inspections. You will manage Quality System (QS) projects, drive timelines, and ensure compliance with FDA and global regulatory standards.

What You'll Do

• Lead and direct the workload of Quality System (QS) projects with key quality deliverables (CAPAs, audits, responses, and system improvements)
• Manage timelines for QS initiatives including CAPAs, audit programs, responses, QMS compliance, and process improvements
• Serve as Backroom Manager for external audits (FDA, Notified Bodies, customers), coordinating logistics, SME support, and post-audit activities (observations, CAPAs, commitments tracking)
• Define scope, deliverables, timelines, and milestones for QMS elements; develop and maintain QMS updates
• Align resources with Program Management and ensure projects meet QMS and regulatory expectations
• Drive continuous improvement of Quality Systems processes and tools; collaborate with Quality, Regulatory, PM, Engineering, Manufacturing, and Operations and Global functions
• Governance & Reporting: generate status updates and escalate/resolution of quality risks
• Manage risk and compliance: identify and proactively manage risks related to regulatory requirements and QS performance

What We're Looking For

• Bachelor's degree in engineering or science or equivalent experience
• Minimum seven years in medical device, pharmaceutical, or regulated industry
• Strong knowledge of Quality Management Systems (QMS), FDA regulations (21 CFR Part 820 / 21 CFR Part 11), ISO 13485, and global standards
• Experience managing CAPA, audits, regulatory inspections, and compliance initiatives
• Excellent attention to detail, communication, problem-solving, analytical, and organizational skills
• Ability to manage multiple priorities in a fast-paced environment
• Proficiency in Microsoft Office; ERP experience (e.g., SAP)
• Preferred: Certified Quality Auditor (CQA), Six Sigma, or similar certification
• Experience as an audit backroom lead
• This role does not have direct supervisory responsibilities

Nice to Have

• Certified Quality Auditor (CQA), Six Sigma, or similar certification
• Experience serving as an audit backroom lead

Compensation & Benefits

• Annual salary: $115,000 - $140,000 plus 15% STI
• Benefits: Health, Dental, and Vision insurance; 401k with company match; Paid Time Off; Wellness initiative and Health Assistance