Director of Quality, Compliance and Audit

Director of Quality, Compliance and Audit page is loaded## Director of Quality, Compliance and Audit locations:
Cambridge (US), Massachusetts, United States:
Nashville, Tennessee, United States:
Orange (OH), Ohio, United States:
Plymouth, Minnesota, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
575368### Job Title Director of Quality, Compliance and Audit###

Job Description The Director of Quality, Internal Audit and Compliance Engineering lead the global Internal Audit program and the shared services Compliance Engineering function across the Philips Quality Enterprise Services organization. Accountable for ensuring proactive compliance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 9001) through robust quality systems, risk-based methodologies, and engineering-driven problem solving.

This role drives global inspection readiness, systemic issue prevention, and continuous improvement by integrating CAPA, root cause analysis, risk management, and compliance monitoring into a cohesive Compliance Engineering framework.
** Your role:
**** Compliance Engineering
*** 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
** Internal Audit & Inspection Readiness
*** 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
** KPI & Compliance Performance Management
*** 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
** People Leadership & Organizational Development
*** 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
* Ensure 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
** You're the right fit if:
*** You have a minimum of 15+ years of experience in the medical device industry with a strong focus and relevant experience in Compliance Engineering, CAPA, Internal Audit, and Quality Systems
* You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001.
* You have experience supporting regulatory inspections (FDA, Notified Bodies)
* You have proven functional and strategic leadership in global, matrixed organizations.
* You have a minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field - Master’s degree preferred (MBA, MS, or equivalent)
* You must be able to successfully perform the following minimum Physical,…