Design Quality Engineer

Job Title

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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by .

To find out more about what it's like working for Philips at a personal level, visit the on our , where you can read stories from our . Once there, you can also learn about our , or find answers to some of the .

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