Director of Quality, Compliance and Audit

Role Overview

• Owns the global Compliance Engineering function, integrating CAPA, root cause analysis, risk management, and systemic issue prevention
• Drives proactive identification and mitigation of compliance risks across the QMS
• Ensures robust problem-solving methodologies are consistently applied (e.g., 5 Whys, Fishbone, Fault Tree, statistical analysis)
• Leads governance forums to review systemic issues, trends, and escalations
• Ensures CAPA remains effective as a subset of the broader Compliance Engineering framework
• Owns the global internal audit program, including risk-based audit planning
• Leads mock FDA inspections and enterprise readiness activities
• Ensures audit findings are effectively addressed, trended, and prevented from recurrence
• Serves as a key leader during regulatory inspections
• Manages external audit and compliance engineering vendors
• Defines scope of work, performance expectations, and SLAs
• Ensures vendors performance is consistent and adheres to regulatory and Philips requirements
• Defines auditor qualification, certification, and training requirements
• Assesses and maintains global auditor competency standards
• Standardizes audit tools, methodologies, and reporting
• Establishes and monitors global compliance and quality KPIs
• Drives advanced data analytics, trend identification, and predictive insights
• Provides executive-level reporting on compliance and safety risks
• Leads and develops a global team of compliance engineers and audit professionals
• Ensures appropriate resource allocation, workload balance, and technical capability
• Builds succession plans and develops specialized compliance and engineering skillsets
• Ensures team performance and talent retention, as well as improving employee engagement scores
• Owns annual budget for Internal Audit & Compliance Engineering function
• Optimizes cost vs. compliance and quality outcomes
• Aligns resources with enterprise risk and strategic priorities
• Drives simplification, harmonization, and digitalization of QMS processes
• Embeds risk-based thinking and preventive quality into business processes
• Leads enterprise initiatives to transition from reactive CAPA to proactive compliance engineering

Requirements

• Minimum of 15+ years of experience in the medical device industry
• Strong focus and relevant experience in Compliance Engineering, CAPA, Internal Audit, and Quality Systems
• Robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001
• Experience supporting regulatory inspections (FDA, Notified Bodies)
• Proven functional and strategic leadership in global, matrixed organizations
• Minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field
• Master’s degree preferred (MBA, MS, or equivalent)

Benefits

• PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement