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In this role, you have the opportunity to

Support, contribute and influence the Quality, Reliability and Safety of Medical Devices while maintaining compliance to our internal and external processes, standards and regulations.

Contribute to quality objectives by improve customer experience (voice of the customer), Complaint Rate (Cost of Non-Quality, Recalls, Complaints, DEFOA) and First Past Yield (avoid scrap, rework etc).

You are responsible for

• providing oversight of the Design Control process and deliverables as part the different stages of product development including lifecycle maintenance

• providing oversight of the performance of product, within the project, as this relates to Product Quality and Reliability Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely and constructive fashion

• Participating in establishing the quality and reliability strategy within the project specific to the product(s) in scope

• Contribute to the execution and delivery of results specific to product quality: Review of quality and reliability plans (including Risk Management) and ensure this covers all phases of the project; Review key quality related requirements like: Usability, reliability, product performance, manufacturability, safety, security, privacy, serviceability, sustainability etc.; Ensures a proper transfer of design specifications to manufacturing, supply chain and service

• Applies and facilitates data driven Design for Quality & Reliability best practices in the Project like FMEAs, robust design, V&V, root cause analysis & problem solving

• Define and establish best practices and leveraging from across the organization (locally and globally).

• Watch out for new techniques/methodologies to improve product quality, and analyze them and if appropriate plan to apply / deploy them in the organization

You are a part of

CT/AMI Q&R Organization. in this role you'll provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners and work as part of a cross-functional, collaborative, global teams.

To succeed in this role, you should have the following skills and experience

• Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience

• Preferably, experience in highly regulated and complex industry. Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, MEDDEV, EU MDR.

• Preferably capable of conducting internal audits, supporting or handling notified body audits/FDA audits/ internal audits

• Demonstrated success in leading change for product quality and reliability.

• Ability to support development, manufacturing, field data analysis and develops intelligence in estimating current performance and future trends

• Proven ability to successfully incorporate and manage stakeholder needs throughout a project. Ability to build consensus at all levels including global interactions.

• Communicate globally, across teams and programs, from senior leaders to administrative support personnel

• Detail oriented and able to see the big picture

• Experience working in a fast paced, stressful & challenging environment.

• Excellent English skills, written and spoken

In return, we offer you

Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already.

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 .

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