Sr. Quality Engineer

Sr. Quality Engineer (Randstad Contingent Worker)

This position may be remote, but a local candidate is preferred.    

In this role, you will 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 will be 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.

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

EDUCATION:

• 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.

EXPERIENCE

• 5+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System.

You will be a part of:

An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

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.