Senior Quality Lead - Quality Compliance

Philips is seeking a Senior Quality Lead - Quality Compliance with 5+ years of experience in quality engineering, manufacturing, and operations. This role involves acting as a Subject Matter Expert for non-conformance, driving reduction and process validation maturity, and ensuring global Quality and Regulatory compliance. The lead will oversee Quality Assurance activities across the product lifecycle, from new product introduction to ongoing manufacturing and supply chain, impacting quality systems and processes globally. The position requires strong leadership, communication, and data-driven decision-making skills, with a focus on Product Quality and Patient Safety.

Must Have

• Act as Subject Matter Expert (SME) for non-conformance
• Drive non-conformance reduction and process validation maturity
• Implement and provide oversight of consistent global Quality and Regulatory requirements
• Ensure appropriate standards and processes for new product introduction and ongoing manufacturing
• Oversee Quality Assurance activities in manufacturing processes and supply chain
• Serve as best practice/quality resource or technical expert on functional or cross-functional teams/projects
• 5+ years of experience in quality engineering with a full understanding of manufacturing and operations
• Relentless focus on Product Quality and Patient Safety
• Demonstrated leadership skills and ability to influence change and challenge status quo
• Strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge)
• Working knowledge of appropriate global medical device regulations, requirements and standards
• Strong knowledge of Risk Management, Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities
• Bachelor’s degree or higher in Engineering or related field (Mathematics, Statistics, etc.)
• Lean Six Sigma Green or Black Belt (or Master Black Belt) certified
• Excellent communicator with strong negotiation and relationship management skills
• Strong ability to make data-driven decisions and move teams through vague and complex situations
• Willingness and ability to travel globally (US, Europe, India, China) up to 25%

Perks & Benefits

• Flexible role
• Opportunity to work with international teams
• Office-based working model (spend at least 3 days working from the office and up to 2 days from home)

Job Title

Senior Quality Lead - Quality Compliance

Job Description

Your role:

• Acts as Subject Matter Expert (SME) for non-conformance, and Drive non-conformance reduction and process validation maturity in close cooperation with the Quality leads in Integrated Supply Chain.
• Implement and provide oversight of consistent global Quality and Regulatory requirements related to elements supporting the overall operations and process controls.
• Ensures that appropriate standards and processes are in place for new product introduction, as well as for ongoing manufacturing that include all stages of the manufacture of the product/system.
• Oversees the Quality Assurance activities in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and /or procedures for regulated products /businesses.
• Have an impact on processes such as the introduction/validation of new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality systems.
• You serve as best practice/quality resource within your own discipline or as technical expert on functional or cross-functional teams/projects. You also act on a global scale across all Philips businesses and factories.
• This flexible role offers you the opportunity to work with international teams, while benefiting from an office-based working model (spend at least 3 days working from the office and up to 2 days from home). Travel between 20-30% globally is required for strategic and key initiatives, as well as leadership activities.

You're the right fit if:

• You’ve acquired 5+ years of experience in quality engineering, with a full understanding of manufacturing and operations, resolving a wide range of issues in creative ways, including the introduction of new concepts. You have a relentless focus on Product Quality and Patient Safety, and demonstrated leadership skills, and ability to influence change and challenge status quo in respect to opportunities for improvement.
• Your skills include strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge); working knowledge of appropriate global medical device regulations, requirements and standards. Strong knowledge of Risk Management, Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities.
• You have a bachelor’s degree or higher in Engineering or related field (Mathematics, Statistics, etc.), and are Lean Six Sigma Green or Black Belt (or Master Black Belt) certified.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator with strong negotiation and relationship management skills, with a strong ability to make data-driven decision and move teams through vague and complex situations to develop clearly defined programs. Must be willing and able to travel to US, Europe, India and China up to 25%.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence 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 healthcare that we all deserve. Do the work of your life to help the lives of others.

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

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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

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