Systems Design Quality Engineer (E2W)

Job Title

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.

Youre the right fit if:

Minimum required Education:
Bachelors / Masters Degree in Mechanical Engineering Electronics Engineering Science or equivalent.

Minimum required Experience:

• Minimum 5 years of experience with Bachelors 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

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If youre 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.