In this role, you have the opportunity to:
Guide and support Business Groups, Markets and enabling functions to- “always do the right thing”. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for:
• Maintain and manage QMS processes for quality, compliance, and effectiveness. Review and update QMS procedures, support inspection and audit activity, responsible for QMS process areas as assigned.
• Perform gap assessments, develop and manage quality plans, provide metrics and status reports as appropriate.
• Ensure the product team follows the QMS throughout the product lifecycle, coaching and mentoring the team for QMS activity as well as actively participating as the project QE.
• Provides effective oversight of all design related activities during the product lifecycle, including compliance planning.
• Participate in product planning, requirements development, criteria establishment, design reviews and DHF reviews
• Assists with FMEA, Risk Management and Development efforts with Quality Tools and investigations.
• Review test and performance data, perform complex root-cause analysis, drives improvement and remediation activity with the development team.
• Use post-market analytics and statistics to report on product performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required
• Analyze and review product quality issues/trending, driving continuous improvement
• Lead Supplier Management activity, including: supplier metric reviews, complaints, trend analysis, supplier audits, author and review supplier quality agreements, maintain the ASL, initiate and manage SCARs, capture and report metrics as appropriate.
• CAPA process management activity, including any of: scheduling and conducting CRB, assisting CAPA owners to keep CAPA content compliant and activity on-schedule, own Q&R CAPAs, capture and report metrics as appropriate.
You are a part of:
An organization helping to transform healthcare, expanding the ability to serve larger clinical patient populations and making specialized clinical expertise broadly available.
The person in this role must be comfortable working as an individual contributor or as a team member in a fast paced, Agile development environment. Q&R input is necessary throughout the entire process to meet deadlines and address compliance and quality concerns. This role requires a person comfortable with making correct decisions through the analysis and interpretation of incomplete or uncertain data.
The QE workload involves a mix of responsibilities to establish/maintain the organization QMS and software/ hardware product support. With the implementation of the MDSAP program, the transition of MDD to EU MDR, and the General Data Protection Regulation, there is plenty of change management and challenges to address while maintaining a compliant QMS program. In addition, the Q&R team not only supports PHM products, it also participates in the Philips Quality Transformation initiative, providing Q&R exposure to the broader Philips organization.
We are looking for:
A person who is excited by the unique professional challenges presented by our Tele-health products, has strong technical competencies, and demonstrates resilience in challenging situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else, in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.
To succeed in this role, you should have the following skills and experience:
• Bachelor’s degree in Computer Science, Engineering or related disciplines.
• Minimum of 5+ years’ experience in Quality Engineering in an FDA regulated, ISO 13485 QMS, Medical software or systems, product environment
• CAPA’s, FMEA, Risk Management, Root Cause Analysis, Troubleshooting
• Design Review/Controls
• Competency working with requirements of FDA 21 CFR Part 820, ISO 13485, ISO 62304
• FDA Inspection and Internal and External Audit Support
• Design Verification/Validation
• Working knowledge of appropriate global regulations, requirements, and standards
• Data Analysis, Trend Analysis
While not required, the following skills are preferred:
• Experience with Software Agile Methodology
• Experience working with suppliers/vendors
• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt / Black Belt
• MDD/EU MDR
- must have items: Technical / engineering background, product development under medical device design controls, risk management utilizing DFMEAs, complaint and product investigations
- nice to have items: ASQ CQE, regulatory experience, Six Sigma, Blackbelt
- reason for hire
• There is a project that requires temporary additional support- Thermometer complaints / follow up