Director of Quality, Compliance and Audit

Job Title

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

Youre 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 Bachelors degree (Required) in Engineering Life Sciences or related technical field - Masters degree preferred (MBA MS or equivalent)
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence (5 days per week) in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations. This is an Office-based role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Cambridge MA is $18100 to $286960
• The pay range for this position in Plymouth MN is $17000 to $270900
• The pay range for this position in Nashville TN and Orange OH is $16200 to $258000

The actual salary offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills experience business needs geographical location and internal equity.

At Philips it is not typical for an individual to be hired at or near the top end of the pay range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition other compensation such as an annual incentive bonus sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program which includes a generous PTO 401k (up to 7% match) HSA (with company contribution) stock purchase plan education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa now or in the future.
• Company relocation benefits WILL NOT be provided for this position. For this position you must reside in or within commuting distance to Cambridge MA Plymouth MN Nashville TN Orange OH.
• May require travel up to 40%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.