Design Quality Engineer

Job Description

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 Computer Science, Computer Applications or equivalent

Minimum required Experience:

Minimum 6 years of experience in Software Quality Engineering

Preferred Certification:

ISO 13485, ISO 9001

Preferred Skills:

• Design Quality Management 21 CFR 820, EUMDR
• 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
• Software Development Life Cycle (SDLC)
• Product Quality and Reliability
• Defect Management
• Design Verification Planning
• Design Validation Planning
• Product Test Design

In return, we offer you

A meaningful career, with new challenges in our dynamic organization, working in an encouraging multinational and multicultural environment. We are happy to provide you with this opportunity to work with new technologies. You will be surrounded by passionate and committed, colleagues who share your ambition to create outstanding customer experiences. Your work will be ambitious and full of opportunities for growth. Variety and challenge will be part of your daily routines.

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 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.

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.

#LI