Please note that this is an "onsite" role, and the successful candidate will be expected to work from our Tilburg (Netherlands) facility.”

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 

The Principal Quality Engineer is a key leader within the organization, responsible for overseeing and maintaining the integrity of the Quality Management System (QMS). This role ensures compliance with internal and external quality standards through the execution and approval of process and test method validations, risk management activities, and continuous improvement initiatives. The Principal QE serves as a subject matter expert in root cause analysis and nonconformance investigations, applying advanced problem-solving methodologies to drive resolution and prevent recurrence. This position partners closely with cross-functional teams to influence design and manufacturing decisions, ensuring product quality and regulatory compliance throughout the product lifecycle; and provides expertise in the optimization of product development.

How you will make an impact:

• Provide leadership and oversight of the Quality Management System (QMS), ensuring compliance with applicable standards, driving continuous improvement initiatives, and maintaining the integrity of quality processes and documentation.
• Lead and approve process and test method validations, including the development and review of protocols and reports, ensuring robust and compliant verification of product performance and reliability.
• Strong capability in Quality Data Review, including monitoring and analyzing quality metrics, identifying adverse trends, escalating as needed, and leading quality metric review meetings.
• Investigate nonconformances and quality issues using structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, DMAIC), and drive effective corrective and preventive actions (CAPA) to resolution.
• Serve as a key quality representative in cross-functional teams to evaluate risk, influence design and process changes, and ensure alignment with regulatory and customer requirements throughout the product lifecycle.
• Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
• Train, coach, and guide lower-level employees on more complex procedures
  
   

What you’ll need (Required Qualifications):

• Bachelor's degree in engineering or scientific field plus at least six (6) years of experience within Quality Engineering or Manufacturing Engineering; OR Master’s degree in engineering or scientific field plus at least five (5) years of experience within Quality Engineering or Manufacturing Engineering
• Experience working within a highly regulated industry
• Experience with and providing technical guidance on NCRs, CAPAs, and root cause analysis

What else we look for (Preferred Qualifications):

• Engineering degree
• Medical Device (highly preferred) or Pharma industry experience
• Experience and strong knowledge of Quality Management Systems (QMS) and manufacturing principles
• Demonstrated experience leading and executing equipment/process validations activities (i.e. IQ/OQ/PQ and Test Method Validations)
• Experience with either reviewing, creating, authoring, and approving risk management documents (i.e. pFMEAs and dFMEAs); and strategizing on risk management activities
• Proven experience with manufacturing operations, including receiving inspections, in-process inspections, non-conformance management, and process validations
• Experience conducting audits and ensuring compliance with regulatory standards and quality management system requirements.
• Comprehensive understanding of related aspects of quality engineering processes and/or systems
• Knowledge of Six Sigma methodologies and tools
• Excellent interpersonal relationship skills including negotiating and relationship management skills
• Problem-solving, organizational, analytical, and critical thinking skills

What is it like to work at Edwards Lifesciences in Netherlands?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in Netherlandsalso offers the following benefits:

• Competitive Compensation and Benefits package
• Flexible working hours, remote working
• Pension Plan
• Risk Insurances
• Health Allowance
• Enhanced Leave Benefits
• Service Awards
• Transportation Programs
• Employee Stock Purchase Program
• Employee Assistance Program

Comprehensive Well-being Program Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.