Design Quality Engineer

Job Title

Design Quality Engineer

Job Description

Job Title: Design Quality Engineer

In this role, you have the opportunity to

Be part of the team delivering meaningful innovation to improve people’s health.

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

Patient safety and quality team who work closely with business units, regions and functions to foster a culture of patient safety, quality and integrity at Philips

To succeed in this role, you should have the following skills and experience

• Engineering Graduate in computer science engineering or related field

• Over all 12 years within technology industry and Min 08 years in Software quality management function within Medtech Industry

• Expert in ISO 13485, ISO 14971, IEC 82304, IEC 62366, EUMDR, 21CFR820

• QMSR, Software tool validation, Correction and removals

• Expert in design controls, CAPA, Compliant handling process

• Proficient in data analysis, RCA, performance dash boards, reliability engineering

• Good understanding of Software development methodology and various technologies (Cloud and platform solutions)

• Passion for patient safety and quality in fast paced Medtech industry

About PhilipsWe 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.

How we work at PhilipsOur 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 – which for full-time employees translates to 3 days working from the office and up to 2 days from home – 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 commitment to inclusion and diversity

At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou.

Our hybrid working model is defined in 3 ways:We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.We want to be at our best: 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.

Why should you join Philips?Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.