Sr. Quality Engineer

Job Description

Job Title : Sr. Quality Engineer

Job Responsibilities:
u2022 Guides the implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under general supervision.
u2022 Ensures the smooth execution of 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 Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
u2022 Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
u2022 Reviews and constantly evaluates product and system designs, guides the analysis of 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 Shares subject matter expertise and suggests proactive methods to strengthen risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
u2022 Addresses and resolves quality engineering issues of medium to high complexity, applying established processes and policies to provide efficient resolutions.
u2022 Suggests efficient utilization of post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
u2022 Prepares for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.
u2022 Applies continuous improvement techniques to enhance quality practices and maintain readiness for quality audits, ensuring adherence to both internal and external standards.

Minimum required Education:
Bachelor's Degree in Mechanical Engineering, Electronics Engineering or equivalent

Minimum required Experience:
5-7 years of experience in Quality Engineering, Safety Engineering, R&D Engineering or equivalent

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.
u2022 Learn more about .
u2022 Discover .
u2022 Learn more about .
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 .