Job Description
In this role, you have the opportunity
• Take charge of the development, improvement and validation of processes, tools and equipment of the Manufacturing systems, leading to predictable, reliable, stable and efficient production processes. Support Project Antigua form an ISC engineering discipline to help keep the project on schedule.
• Review, escalate and deploy the product changes from/to suppliers including material, equipment, process, end of life. Etc.
You are responsible for:
• Collaborate with R&D, QA, Project Antigua and supply chain teams to align on product requirements
• Evaluate new technologies for future development
• Support process-related issues through root cause analysis and corrective actions
• Maintain detailed records of process changes, validations through the DHF and DMR
• Work closely with R&D, Project Antigua and ISC teams to ensure seamless product transitions
• Oversee the transfer of products from development to external manufacturing sites ensuring compliance with industry standards
• Supplier meets quality requirements and standards
• Support APQP Deliverables
• Monitor supplier performance and conduct supplier audits to ensure compliance to quality standards
• Implement supplier corrective and preventive actions to address quality challenges
• Enhancing supplier capabilities and performance
• Optimizing processes to ensure compliant and efficient manufacturing
• Evaluation and selection of equipment and systems to support suppliers
• Provide training and support to suppliers to improve processes through continuous improvement objectives
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you’ll need a customer-first attitude and the following
• BS Engineering discipline or technical field, major in Elec-mechanical, electronical, Industrial, or mechanical engineering education is preferred.
• 5+ years of experience in Operations, manufacturing engineering related functions, supplier management. Project management If they have strong engineering background
• General understanding of product development process and design control is preferred/required
• Ability to work in a cross functional environment at remote locations
• Strong interpersonal and communication skills required
• Methodical, effective troubleshooting/problem solving skills required
• Experience IQ, OQ, PQ Validation Strategies preferred
• Experience with notified bodies(China NMPA/ USA FDA) regulated medical device manufacturing in a Lean production environment preferred