nullIn this role, you have the opportunity toGuide 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 forMaintain 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 Design Control and Clinical Management activity as they pertain to design controls.
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.
Laboratory oversight to maintain compliance to applicable standards and laboratory practices (GLP's).
You are a part ofAn 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.To succeed in this role, you should have the following skills and experienceUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Bachelor’s degree in Computer Science, Engineering or related disciplines.
Minimum of 8+ years’ experience in Quality Engineering in an FDA regulated, ISO 13485 QMS, Medical software or systems, product environment
Experience managing and delivering CAPA’s, FMEA, Risk Management, Root Cause Analysis, Troubleshooting
Conduction Design Review under Design Controls
Managing Regulated Laboratory Practices
Competency working with requirements of FDA 21 CFR Part 820, ISO 13485, ISO 62304, and ISO 9001
Managing FDA Inspections and providing Internal and External Audit Support
Overseeing / Approving Design Verification/Validation plans, protocols, and reports
Working knowledge of appropriate global regulations, requirements, and standards
Conducting Data Analysis, Trend Analysis
Experience with Software Agile Methodology preferred
Experience working with suppliers/vendors preferred
ASQ Certified Quality Engineer (CQE) preferred
Six Sigma Green Belt / Black Belt preferred
Why should you join Philips?Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran#LI-PH1