Job Description Job title: RA International Coordinator & Data Analyst. You are responsible for Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle Performs independent technical assessment on product quality performance and post-market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required. Performs independent technical assessment on product quality performance and post-market product quality analysis Provide leadership and oversight to ensure Quality Management System Compliance Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving) You are a part of The Philips Hospital Respiratory Care business group, supporting products including invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.u00A0u00A0 We believe that by understanding our customersu2019 problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device. To succeed in this role, youu2019ll need a customer-first attitude and the following u200BEngineering Degree or equivalent experience in medical device industry 5+ yearsu2019 experience with a medical device company preferably Can Lead quality related problem solving and root cause analysis during design and manufacturing Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.) Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, Usability. Have an understanding of Sample Size Determination and Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis-. Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements. Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up. Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving. In return, we offer you A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities. How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. 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. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .
