Software Design Assurance Quality Engineer

AI in this role

Software design assurance quality engineer responsible for documentation, compliance, risk management, and software design reviews.

software-quality-assuranceregulatory-compliancerisk-managementroot-cause-analysis

Job Title

Job Description

Job Title : Software Design Assurance Quality Engineer

Job Responsibilities:
• Facilitates the development, maintenance, and management 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 limited supervision.
• Leads 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.
• Validates 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.
• Provides 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.
• Ensures 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.
• Acts as a subject matter expert, providing guidance to meet schedules, resolve technical problems, and manage performance requirements, including mentoring on quality engineering practices, regulatory compliance, and QMS processes.
• Monitors, and reports on key software quality metrics, ensuring these metrics are aligned with business objectives and regulatory expectations, while communicating quality-related performance indicators to relevant stakeholders.
• Helps to identify opportunities for process improvements within software quality engineering, advocating for and implementing best practices, tools, and innovative methodologies to enhance software quality and regulatory compliance.

Minimum required Education:
Bachelor's / Master's Degree in Computer Science, Computer Applications or equivalent.

Minimum required Experience:
Minimum 6-7 years of experience with Bachelor's/Master's degree in areas such as Software Quality Engineering or equivalent

Preferred Skills:

Software Development Life Cycle (SDLC) - mandatory
Defect Management - mandatory
Design for Quality (DFQ) - mandatory
Design Quality Management
Cloud experience preferrable
Health IT experience
Data Analysis & Interpretation
Root Cause Analysis (RCA)
CAPA Methodologies
Regulatory Requirements
Privacy, Safety and Security Risk Assessment
Technical Documentation
Continuous Improvement
Product Quality and Reliability
Design Verification Planning
Design Validation Planning
Product Test Design

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

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 improve the lives of others.

Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Learn more about our culture.

How we rate this

Software Design Assurance Quality Engineer at Philips rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.

Prepare for this job

A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.

Skills and AI tools this role asks for

Software Quality AssuranceRegulatory ComplianceRisk ManagementRoot Cause Analysis

Questions you could be asked

Tell me about a project where software quality assurance was part of your work. What did you do?
Tell me about a project where regulatory compliance was part of your work. What did you do?
Tell me about a project where risk management was part of your work. What did you do?
Tell me about a project where root cause analysis was part of your work. What did you do?

Adapt your resume

List these exact terms on your resume: Software Quality Assurance, Regulatory Compliance, Risk Management, and Root Cause Analysis. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.

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