Software Quality Engineer
Software Quality Engineer
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 Software QE.
- Provides effective oversight of all design related activities during the software 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 software 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.
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 Software QE workload involves a mix of responsibilities to establish/maintain the organization QMS and software 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 eICU, it also participates in the Philips Quality Transformation initiative, providing Q&R exposure to the broader Philips organization.
The following links will let you explore the Tele-ICU and the Philips eICU product.
What is Tele-ICU?
Philips eICU Program
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 Software Quality Engineering in an FDA regulated, ISO 13485 QMS, Medical software or systems, product environment
- CAPA's, FMEA, Risk Management, Root Cause Analysis, Troubleshooting
- Software 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
- Software 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 Agile Methodology
- Experience working with suppliers/vendors
- ASQ Certified Software Quality Engineer (CSQE)
- Six Sigma Green Belt / Black Belt
- MDD/EU MDR
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 .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
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