Director of Quality, Compliance and Audit
Philips Iberica SAU, Cambridge, MA, United States
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
Assess and maintain global auditor competency standards
Standardized 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, 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 company’s facilities. Field roles are most effectively done outside of the company’s 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 won't 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 $181,00 to $286,960
The pay range for this position in Plymouth, MN is $170,00 to $270,900
The pay range for this position in Nashville, TN and Orange, OH is $162,00 to $258,000
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%.
#LI-PH1
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.
#J-18808-Ljbffr
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
Assess and maintain global auditor competency standards
Standardized 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, 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 company’s facilities. Field roles are most effectively done outside of the company’s 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 won't 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 $181,00 to $286,960
The pay range for this position in Plymouth, MN is $170,00 to $270,900
The pay range for this position in Nashville, TN and Orange, OH is $162,00 to $258,000
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%.
#LI-PH1
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.
#J-18808-Ljbffr