In this role, you have the opportunity to support activities required to ensure reliability & quality of the design. Work with key stakeholders to design, implement and maintain business solutions to address management of reliability requirements, clinical relevant test methods and Design Verification test plans, execution and reports
You are responsible for
Establish and oversee systems for the escalation, monitoring and communication of key quality issues
Establish processes to ensure findings, risks, recommendations and outcomes are clearly documented and communicate
Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
Provide oversight and monitoring of all phases of design to ensure compliance and timely resolution. Support and lead FMEA/Risk Management processes and activities.
Hands on experience on Reliability engineering and Life cycle test
Work with business process owners to devise appropriate metrics to improve product and process
Establish Quality Assurance process metrics. Trend, analyze, and report on quality data; develop recommendations based on data analysis
Facilitating and owning CAPAs and driving it to closure
Support Post Market Product Assurance and audit groups in post-market activities.
Work with business process owners to identify and implement solutions to track cost of poor quality . Evaluate for completeness, effectiveness and proper identification of root cause
Monitor the effectiveness of implemented actions and overall effectiveness of the system
Establish and support best practices for problem solving, root cause analysis, and solution selection tools
Provide subject matter expertise during internal and external quality system audits.
Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion
To succeed in this role, you should have the following skills and experience
Engineering degree in Mechanical or Electronics/Bio medical /Life sciences with over 10 years of experience.
Sound knowledge of implementing and sustaining Quality Management system compliance as per ISO Regulations (ISO13485/ USFDA QSR)
Demonstrated external audit management capabilities like handling Notified body audits/FDA audits/ Internal audits with stake holder management &Follow up for E2E corrective actions completion
Superior knowledge/application of all Quality System elements within Medical device Industry
Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues./Expertise in Gap assessments wrt to new regulation’s/standards and drive the compliance program
Demonstrated record of successful project management, process development, and process improvement in QMS implementations and trainings
Superior communication and mentoring skills, ability to build consensus at all levels including global interactions
Demonstrated quality training delivery experience.
NPI and design transfer experience will be an added advantage.
In return, we offer you
A rewarding career in Philips with attractive package. `
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
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. Learn more by watching this video .
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 .