Product Quality Engineer
Product Quality Engineer (Randstad Contingent Worker)
In this role, you will have the opportunity to:
Support the Quality, Reliability and Safety of Medical Devices. You will work in an independent Quality & Regulatory organization with key stakeholders during various stages of the design, development and maintenance of the medical device. Your main and initial focus is to implement design Quality practices to ensure designs are properly assessed to assure patient safety and product efficacy.
You will be responsible for:
• Oversight and implementation of product & process performance to ensure designs are properly assessed to assure patient safety and product efficacy.
• Contribute to the execution and delivery of results specific to product quality and compliance to Medical Device Regulations (e.g. Design Controls).
• Apply and facilitate data driven Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)
• Go through the history of quality and compliance issues (Perform independent quality and compliance checks, leverage data of post-market analysis like Complaints, Quality Notifications, DeFOA, Defect) and drive or support the improvement through processes like CAPA.
• Support and lead quality and compliance related problems. Utilizing root cause analysis tools and define, establish and deploy best practices.
To succeed in this role, you should have the following skills and experience:
• Bachelor’s degree with up to 5 years of related experience or Master’s degree with 3+ years of related experience in highly regulated and complex industry (Medical Device = preferred)
• Applied knowledge and / or exposure to (medical device) Design Control Process and practices as they relate to patient safety and product efficacy to ensure continued audit & inspection readiness.
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
• Experience or understanding of Design Control Practices (e.g. Design Change, Verification and Validation, Requirements Management etc), Risk management, RCA, CAPA.
• Experience or qualification: Design for Six Sigma and Statistics or proven experience in problem solving and root cause analysis tools, Design for Reliability, FMEA, Usability, APQP, Design Form Manufacturing and Test, Meddev awareness, AAMI Design Controls / Risk Management, Program management
• Demonstrated success in supporting change for product quality and reliability
You will be a part of:
The Q&R organization of MR / IC and DXR and provide support to the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare. You will be located in the USA and work closely with your peers in the USA, The Netherlands, India and China.
We are passionate about serving our customers and making a meaningful contribution to (product) quality. You will work in cross-functional project (core) teams consisting of, amongst others, R&D, Service, and Industrialization. In addition, you will have the ability to interact across different sites as a benefit of being part of a global organization.
In return, we offer you:
Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.
Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.