supplier quality principal engineer.

•Lead implementation of Supplier Change Requests and utilize Production Part Approval Process (PPAP)
•Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D
•Ensure supplier quality systems adhere to all applicable regulations and standards
•Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance
•Apply experience and knowledge of FDA, MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems),cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance
•Drive new process, system implementation within supplier quality lifecycle team
•Identify and lead continuous process/products improvement/excellence initiatives/projects
•Ensure supplier quality systems adhere to all applicable regulations and standards

Qualifications
•Bachelor degree in Science or Engineering, advance Degree preferred.
• 5 years experience as minimum, of which in manufacturing quality/Engineering quality/supplier quality in medical device industry preferred.
•Solid experience/knowledge of quality process management and tools e.g. APQP, PPAP, SPC, Statistics Tools and Analysis in development and revision of Quality Sampling Plans based on product and patient risk.
•Apply experience and knowledge of ISO 13485 (Quality Management Systems), FDA medical device regulations, cGMP, and Risk Management (ISO 14971) to instil a culture dedicated to ensuring patient safety and sustained regulatory compliance
•Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance
•Ability to lead and influence cross-functional teams, including Procurement, Regulatory Affairs, Technical Services and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance
•Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans
•Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations
•Proficient English, working language for reading, writing and oral communication.
•> 20% travel expected