We welcome you to join Volcano a Philips Company as a Senior Design Quality Assurance Engineer in our San Diego, CA location.
In this role, you have the opportunity to work with a cutting edge product line - IGT Devices is part of the Philips Image Guided Therapy (IGT) at https://intranet.philips.com/Pages/Image-Guided-Therapy.aspx business group. As a Senior Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the development of new medical devices and existing device design changes.
If you have a background in disposables – ideally with experience in electromechanical products - then we would love to talk with you!
You will apply company policy and procedures to analyze situations or data and draw conclusions. Assignments will include creating, reviewing and updating documents, auditing Design History Files and actively participating as a core member of a product development team including requirement generation, risk management, detailed design, verification and validation activities and design transfer to production.
The Senior Design Assurance Quality Engineer will also update existing Work Instructions and play a role in creation of new Work Instructions.
You are responsible for
Understand and implement the processes and intent of all aspects of the QMS related to Design Controls
Using engineering principles, analyze situations or data to identify gaps between project work and the QMS
Work with product development teams and other QEs to assure compliance to the QMS
Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles
Lead Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
Lead shelf life and biocompatibility testing and create associated test procedures and reports
Create and update product risk analyses and risk management files
Develop and implement new and improved quality/compliant pre-market engineering methods, techniques and processes.
Build stable relationships internally
You are a part of
Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.
To succeed in this role, you should have the following skills and experience
Requires a B.S. degree in Science, Engineering or associated fields
Minimum of 8+ years’ experience in Quality Assurance, including Quality systems, standards, metrics, and tools
Minimum 6+ years’ experience in medical device industry
Background in disposables
Experience with electromechanical products
Must have experience working with New Product Development projects and design controls
Must have organizational and interpersonal skills working in a cross-functional teams
Ability to organize and prioritize workflow in order to meet established time frames and schedules
Certified Quality Engineer (CQE)
Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO10993)
Mastery of software programs - Microsoft Excel, PowerPoint, and Word
Travel: 10% domestic and/or international
In return, we offer you
We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video
Find out more info about Philips at www.philips.com/na/careers
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.