Risk Management Quality Engineer

This role can be remote but prefer a candidate in Carlsbad, CA.

In this role, you will have the opportunity to:

Be a key developer in expanding our Quality & Regulatory Risk Management team for our Connected Care organization. Create and implement new tools and methods to manage risk, which will contribute to the safety and efficacy of medical products that save lives and improve health.
 

You will be responsible for:

Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.
• Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
• Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
• Conduct analysis of existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
• Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
• Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.
• Create and continually improve procedures and work instructions to ensure reliable, repeatable results.
• Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.
 

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

• BS in Engineering or a related field. MS preferred.
• 4+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry. 2+ years’ experience with a MS or higher.
• Extensive hands on experience with the ISO 14971 standard.
• Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
• Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
• Demonstrated expertise in managing complex projects and implementing cultural change.
• Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
• Experience working within a Quality Management System.
• Green Belt or Black Belt certification preferred.
• Excellent team work skills including influencing and building rapport with internal customers and stakeholders.

You will be a part of:

You will be part of Quality & Regulatory Risk Management team for our Connected Care 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.