Design Quality Engineer

Job Description

Job Title: Design Quality Engineer

Job Responsibilities:
u2022 Facilitates implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under direct supervision.
u2022 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.
u2022 Produces and maintains detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
u2022 Executes quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
u2022 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.
u2022 Ensures validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements.
u2022 Provides expertise and contributes to risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
u2022 Addresses and ensures resolution of quality engineering issues of low to medium complexity, applying established processes and policies to provide efficient resolutions.
u2022 Utilizes post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
u2022 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.

Preferred Experience:

• 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:
u2022 Design Quality Management
u2022 Data Analysis & Interpretation
u2022 Design for Quality (DFQ)
u2022 Root Cause Analysis (RCA)
u2022 CAPA Methodologies
u2022 Regulatory Requirements
u2022 Privacy, Safety and Security Risk Assessment
u2022 Technical Documentation
u2022 Continuous Improvement
u2022 Product Quality and Reliability
u2022 Defect Management
u2022 Design Verification Planning
u2022 Design Validation Planning
u2022 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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 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.
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If youu2019re 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 .