Systems Design Quality Engineer (E2W) at Philips

Shenzhen, Guangdong Province, China -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Quality Medical Device Management, Data Analysis & Interpretation, Design for Quality (DFQ), Root Cause Analysis (RCA), CAPA Methodologies, Regulatory Requirements, Privacy, Safety and Security Risk Assessment, Technical Documentation, Continuous Improvement, Product Quality and Reliability, Defect Management, Design Verification Planning, Design Validation Planning, Product Test Design

Industry

Hospitals and Health Care

Description

Job Title Systems Design Quality Engineer (E2W) Job Description Job title: Systems Design Quality Engineer (E2W) Your Role & Responsibilities: • Assesses medical device suppliers, products, verification, product safety risk, regulatory compliance for suitability and effectiveness for global markets • Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision. • Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. • Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements. • Ensures success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability. • Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence. • Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements. • Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality. • Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary. • Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards. • Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement. • Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle. • Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones. You're the right fit if: Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent. Minimum required Experience: Minimum 5 years of experience with Bachelor's in areas such as product Quality Design Engineering, Product Design Safety Engineering, R&D Engineering or equivalent Minimum 2 years Experience of working with Global product Medical Device Regulations Preferred Education: Electrical / Mechanical Engineering Preferred Experience: Medical Device supplier audit experience / certification (e.g. ISO13485) Preferred Certification: Six Sigma Green Belt Preferred Skills: • Design Quality Medical Device Management • Data Analysis & Interpretation • Design for Quality (DFQ) • Root Cause Analysis (RCA) • CAPA Methodologies • Regulatory Requirements • Privacy, Safety and Security Risk Assessment • Technical Documentation • Continuous Improvement • Product Quality and Reliability • Defect Management • Design Verification Planning • Design Validation Planning • Product Test Design How we work together We believe that we are better together than apart. 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. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. If you’re 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 culture of impact with care here. 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

Responsibilities

The Systems Design Quality Engineer assesses medical device suppliers and products for compliance and effectiveness, while managing the design control process to ensure adherence to quality standards. They also conduct risk management activities and leverage post-market data to drive continuous improvement in product quality.