Senior Validation Engineer

Process Validation & Verification Focus-Senior Supplier Quality Engineer

In this role, you have the opportunity to make a real impact by leading process validation and verification activities across Philips IGTD and Spectrawave product portfolios, ensuring robust, compliant, and scalable manufacturing processes throughout the supply chain. You will partner closely with R&D, Quality, Manufacturing Engineering, Operations, and Supplier partners to establish and maintain validated processes that consistently deliver safe and effective medical devices.

As a key member of the Supplier Quality organization, you will drive process excellence through Advanced Product Quality Planning (APQP), risk-based validation methodologies, supplier qualification, and continuous improvement initiatives. Your expertise in IQ/OQ/PQ, test method validation, and manufacturing process controls will directly support new product introductions, supplier readiness, and sustained production performance.

Your Role

Process Validation & Verification Leadership

• Lead process validation and verification activities across the Spectrawave and IGTD product portfolios, including console and catheter manufacturing processes.
• Develop, execute, and approve validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Partner with suppliers to establish robust validation strategies for manufacturing processes, equipment qualifications, and inspection methodologies.
• Perform Test Method Validation (TMV), process capability assessments, and CTQ/CTS evaluations to ensure compliance with regulatory and business requirements.
• Apply risk-based validation approaches utilizing Design FMEA (DFMEA), Process FMEA (PFMEA), and statistical process control methodologies.
• Ensure validation activities meet applicable regulatory requirements, including FDA Quality System Regulations and ISO 13485 standards.
• Lead validation support for supplier process changes, transfers, equipment upgrades, and new product introductions.

Supplier Quality & APQP

• Drive Advanced Product Quality Planning (APQP) activities across a diverse supplier base consisting of more than 700 components.
• Collaborate with R&D and Design Quality teams to ensure Design for Manufacturability (DFM) principles are integrated into supplier manufacturing processes.
• Support supplier qualification activities, including supplier audits, Quality Agreements, Change Notification Agreements, and ongoing performance monitoring.
• Review and approve Supplier Initiated Change Requests (SICRs), ensuring appropriate risk assessments, validation requirements, and regulatory evaluations are completed.
• Lead First Article Inspection (FAI) investigations and resolution of APQP-related nonconformances.
• Conduct supplier root cause investigations and corrective action management through the Supplier Corrective Action Request (SCAR) process.
• Monitor supplier quality metrics and drive continuous improvement initiatives focused on quality, delivery, and process capability.

Continuous Improvement

• Facilitate Value Stream Mapping and process optimization initiatives across supplier manufacturing operations.
• Analyze process performance, customer feedback, and quality trends to identify opportunities for increased process robustness and efficiency.
• Lead cross-functional problem-solving efforts utilizing structured methodologies such as DMAIC, 8D, and Root Cause Analysis.
• Partner with suppliers to implement sustainable improvements that enhance product quality, reduce variation, and improve operational effectiveness.

You're the Right Fit If

• Bachelor's degree in Engineering required; Master's degree preferred.
• 3 years of experience in Process Validation, Manufacturing Engineering, Supplier Quality Engineering, or Product Quality within a regulated industry.
• Demonstrated expertise in process validation and verification methodologies, including IQ, OQ, and PQ.
• Strong understanding of APQP, PFMEA, DFMEA, Statistical Process Control, and process capability analysis.
• Experience developing and executing validation protocols, reports, and risk assessments.
• Knowledge of test method validation and measurement system analysis.
• Experience working with plastic, metal, and electronic component manufacturing processes.
• Working knowledge of FDA, ISO 13485, and medical device quality system requirements.
• ISO 13485 Lead Auditor certification is a plus.
• Exceptional written, verbal, and interpersonal communication skills with the ability to influence cross-functional teams and supplier partners.
• Ability to manage multiple priorities in a fast-paced, highly regulated environment.
• Willingness to travel up to 20%.

Preferred & Leadership Expectations

• Communication & Influence
• Exceptional ability to collaborate across Quality, Engineering, Operations, and Supply Chain organizations while effectively influencing supplier partners and senior leadership.
• Strategic & Risk-Based thinking
• Ability to navigate ambiguity, identify process risks, and implement practical, data-driven validation and quality solutions.
• Project Leadership
• Strong project management capabilities with a proven track record leading complex validation programs and supplier quality initiatives.
• PMP certification is a plus.

What you’ll gain:

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve lives around the world. It could be life-changing for you too, with the opportunity to embrace new experiences, learn new skills and make new connections.

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional. And as an employee of a Randstad company, you can expect to receive a range of benefits including ongoing support with your personal development and future prospects.

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. As a contractor or freelancer at Philips, you’ll be part of our diverse collaborative team, helping the lives of others through the contribution you make each day.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by a Randstad company and will not be an employee of Philips.

Looking for a different project role?

If this isn’t quite the right project or role for you, you can sign up to our contractor a community to keep up-to-date with the latest projects at Philips https://philips.talent-pool.com/