Job Title

Job Description

• Participate in the supplier sourcing process, lead supplier selection with QMS and technical capability assessment
• Lead APQP, Process capability study, SPC, DOE which is essentially process optimization, understanding QSIT, serving as a Quality interface to suppliers supporting quality and productivity goals.
• Support project team for DFMEA assessment.
• Collaborate with R&D team to define Critical to Quality (CTQ) and Critical to Safety (CTS).
• Represent Philips QMS requirements to Supplier.
• Implement purchasing controls as per PEPF procedures
• Support Design for Excellence ‘Df X’ collaboration between R&D and Supplier.
• Proactively monitoring and measuring product/process quality and performance trends and troubleshooting of production/release issues.
• Develop and oversee system/element/part qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
• Assure quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations.
• Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes.
• Serve as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings.

• Minimum of 5 years of related engineering experience (medical device or regulated industry preferred).
• Wide-ranging experience within an engineering function.
• Well versed in Quality Engineering and Continuous Improvement techniques.
• Direct working relationships with suppliers
• Participated in several NPIs from start to finish.
• Direct shop-floor production engineering sustaining experience
• Works on assignments of high complexity where analysis of situations/data requires evaluation of new factors.
• Applies judgment in selecting methods and techniques.
• Resolves problems independently.
• Receives little to no guidance on routine work, general guidance on new assignments
• Works on assignments of moderate scope and with accountability for functional impact.
• Applies technical and soft skills as a seasoned professional.
• Interacts often with other internal functions and external partners at a level up.
• Provides detailed guidance to others periodically.
• Focus of influence primarily within own function.