Quality & Compliance Coach - Senior Manager

Required Skills & Experience

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• 15+ years of experience within FDA-regulated medical device manufacturing
• Extensive background in Quality Management Systems (QMS), compliance, and regulatory requirements
• Prior experience serving as a Management Representative or equivalent senior quality leadership role
• Significant experience supporting and leading FDA inspections and Notified Body audits
• Demonstrated expertise with both Front Room and Back Room audit processes

Strong working knowledge of:

• FDA 21 CFR Part 820
• QMSR
• ISO 13485
• EU MDR
• ISO 14971
• CAPA
• PFMEA
• Root Cause Analysis
• Nonconformance Management
• Quality Notification Processes
• Proven experience driving inspection readiness and audit preparation efforts
• Strong coaching, mentoring, and team development experience
• Ability to influence leaders, SMEs, and cross-functional teams
• Experience building quality culture and organizational competency in manufacturing environments

Job Description

Day-to-Day Responsibilities

• Serve as the onsite Quality & Compliance Coach for the manufacturing facility
• Lead quality walks and observations to reinforce quality culture and process discipline
• Coach leaders and subject matter experts on regulatory requirements, quality systems, and compliance expectations
• Prepare the site for FDA inspections, Notified Body audits, and other regulatory assessments
• Support Front Room and Back Room audit activities, including inspection strategy and execution
• Identify compliance gaps and help drive corrective actions related to Warning Letter remediation efforts
• Partner with Manufacturing, Quality, Regulatory Affairs, Engineering, and Operations teams to improve quality performance
• Evaluate quality data, audit findings, and operational trends to identify risks and improvement opportunities
• Drive sustainable QMS practices and strengthen overall system effectiveness
• Support CAPA investigations, root cause analysis, and continuous improvement initiatives
• Develop and deliver coaching, training, and mentoring programs to improve site-wide quality competency
• Promote accountability, ownership, and compliance-focused behaviors throughout the organization
• Ensure ongoing inspection readiness through proactive assessments and process improvements
• Support management review activities and quality leadership initiatives