Philips

Director of Quality, Compliance and Audit

Philips

full-time

Posted on:

Location Type: Hybrid

Location: Cambridge • Massachusetts • Minnesota • United States

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Salary

💰 $181,000 - $286,960 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Compliance EngineeringCAPAInternal AuditQuality SystemsStatistical AnalysisData AnalyticsRisk ManagementProblem-Solving MethodologiesAudit ToolsPredictive Insights
Soft Skills
LeadershipTeam DevelopmentResource AllocationWorkload BalanceTalent RetentionEmployee EngagementStrategic PrioritizationCommunicationGovernanceSuccession Planning
Certifications
Bachelor's Degree in EngineeringBachelor's Degree in Life SciencesMaster's Degree (MBA, MS or equivalent)