Facilitates implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under direct supervision.
Executes the design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer, ensuring full compliance with regulatory and quality standards.
Produces and maintains detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
Executes quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
Participates in the evaluation of product and system designs, reviews performance data, and performs root cause analysis to address quality deficiencies and ensure design excellence.
Ensures validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements.
Provides expertise and contributes to risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
Addresses and ensures resolution of quality engineering issues of low to medium complexity, applying established processes and policies to provide efficient resolutions.
Utilizes post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
Prepares for and supports quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.
Minimum required Education:
Bachelor's Degree in Engineering or equivalent.
Minimum required Experience:
Minimum 3-4 years of experience with Vocational Education in Quality Engineering, Safety Engineering, R&D Engineering or equivalent OR no prior experience with Bachelor's Degree.
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Sustaining engineering quality project support to ensure regulations and standards continue to be satisfied through iterative product releases, change control, geographic expansion, cost-down, assurance of supply, CAPA, and quality improvement.
Experience in front room or back room regulatory or standard inspections. ISO 13485, ISO 14971.
Preferred Certification:
Six Sigma Green Belt
Preferred Skills:
Design Quality 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
How we work together We believe that we are better together than apart. 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. Indicate if this role is an office/field/onsite 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 the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If you’re 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.
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