Design Quality Engineer

Job Title Design Quality Engineer Job Description Job Title: Design Quality Engineer In this role, you have the opportunity to The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes. Opportunity to learn End to End product development as Responsible Quality representative driving compliance throughout Product life cycle. Job Responsibilities: Participates in the development and maintenance of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date, and fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under general supervision. Executes the assessment of software designs, including reviewing test and performance data, to ensure they meet quality, safety, and regulatory standards, while identifying and addressing quality engineering deficiencies to embed quality within the design. Conducts in-depth root cause analysis for software quality issues, employing problem-solving techniques to resolve deficiencies and improve software design processes, ensuring that quality is integral to the development process. Guides validation of key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost to ensure they meet customer and regulatory requirements, supporting the delivery of high-quality software products. Ensures effective oversight of the execution of software quality plans and associated risk management activities throughout the software lifecycle, ensuring that all design-related activities are managed according to defined processes. Utilizes post-market analytics and statistics to monitor software performance in the field, providing feedback to manufacturing, suppliers, and design teams, while initiating corrective actions or field actions when required to maintain software quality. Participates in the development of comprehensive Software Quality Plans that cover all stages of the software lifecycle, from design through to post-market, supporting the design of these plans and ensuring adherence to quality and regulatory standards. Possesses and applies working knowledge of relevant global regulations, requirements, and standards, ensuring that all quality activities and software design processes comply with applicable regulatory requirements, facilitating compliance throughout the software development lifecycle. Provides guidance to meet schedules, resolve technical problems, and manage performance requirements, including mentoring on quality engineering practices, regulatory compliance, and QMS processes. Reports key software quality metrics, ensuring these metrics are aligned with business objectives and regulatory expectations, while communicating quality-related performance indicators to relevant stakeholders. Minimum required Education: Bachelor's Degree in Engineering Minimum 5-6 years of experience in Software Quality Engineering or equivalent Have experience in medical industry or high regulated industry Strong quality assurance management experience Strong design control and new product development experience Strong statistical and analytical abilities (e.g. design for six sigma, design for reliability) Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP Professional knowledge in product safety standards (e.g. IEC60601, IEC62366 Usability, etc) Strong communication, problems solving and continuous improvement. Fluent English both in writing and speaking. Strong Influence Skill, Presentation Skill and Dispute solving Skills. In return, we offer you A rewarding career in Philips with attractive package. Extensive set of tools to drive your career, such as a personal development budget, free training and coaching Attractive collective health insurance package Opportunity to buy Philips shares and products with discount Why should you join Philips? Working at Philips is more than a job. It is a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video. To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions. #LI-PHILIN At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights