New Product Introduction Sr QE
- Carlsbad, CA
New Product Introduction Sr QE
In this role, you have the opportunity to
The Sr. Quality Engineer [QE] will be assigned to R&D and Post Market Surveillance teams supporting the design life cycle and transfer of the products into manufacturing, ensuring compliance with the Quality System Regulations, especially 21 CFR Part 803, 806, 820 and ISO 13485. QE in this position will provide independent oversight for system and hardware quality during the design input process, design V&V activities, product realization and contribute to complaint closure, FI analysis and Quality Reviews
You are responsible for
- Ensures appropriate quality and design plans are created that include all stages of the life cycle of the product
- Performs and completes assigned complaints investigations, including but not limited to Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, etc.) and prepare investigation reports.
- Work with cross functional groups such as New Product Development and Sustaining Engineering to ensure Quality problems have been identified and contained.
- Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.
- Evaluation of complaint information received from clinical environments, such as device failure mode, manufacturing documentation review, labeling and instructions for use review.
- Follow up on Implementation of corrective and preventive actions.
- Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use.
- Ensure compliance to EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).
- Performs other duties as needed to ensure compliance with relevant FDA QSRs, EU MDR and other ISO regulations.
You are a part of
The Philips Hospital Respiratory Care business products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers' problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
To succeed in this role, you should have the following skills and experience
- B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly desirable. ASQ (CQE, CRE, CQA) Certifications a plus.
- 5+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System.
- Experience with medical device manufacturing with electronic and/or electromechanical products preferred.
- Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks and projects effectively and efficiently.
- Experience with design review processes, and capable to perform risk analysis in accordance with EN ISO 14971:2012 and develop and document risk mitigation plans desired. Previous experience with SAP MRP or QM module and TW desired
- Working knowledge of EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).
In return, we offer you
Enjoy 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 1 billion lives already. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
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.
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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