QE Safety Compliance Engineer

QE Safety Compliance Engineer (Randstad Contingent Worker)

This position will need to work a hybrid onsite work schedule at our Carlsbad, CA facility.  It will require three days per week in office.     

In this role, you will have the opportunity to:

This position is responsible for managing the Conformity Assessment Operations of the Compliance Safety & Bio-Safety Level 2 Labs, that covers testing and evaluation of a variety of Medical products to the provisions of U.S., Canadian and other International product safety standards (e.g. IEC/ANSI AAMI / CSA 60601-1 and its Collateral and Particular standards).

You will be responsible for:

• Direct interaction with Nationally Recognized Test Labs (NRTL)

• Review emerging regulations and changing standards for potential impact to business. Propose compliance plans to meet changing requirements.

• To develop, maintain and monitor the necessary processes and documentation required to maintain compliance to NRTL level standards.

• To ensure the necessary study plans, protocols, processes, and other documentation are in Compliance with the Regulatory Requirements, ISO 17025 and GLP.

• Interface and participate in site inspections from certification agencies

• To act as a point of contact for Conformity Assessment processes during auditing of laboratories by external & Internal parties, for conformance to ISO 17025 and GLP, and to the Proper WI, QSP and QMS.

• To act as a liaison and assist with Internal & External Audits with NRTL.

• Act as liaison with external testing & certification agencies to assure accurate and cost-effective test strategies are implemented in a timely manner and documented in accordance with applicable global standards.

• Assist product development to ensure continued compliance to the Applicable Standards.

• Assist the manufacturing team to maintain proper testing & product configuration data to support continued compliance.

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

• BS. Electrical Engineering (preferred),

• Master’s degree in Business Administration & Operations (MBA) is Recommended.

• Demonstrated, hands on, 10 + years’ experience in lab management (including knowledge about compliance testing, obtaining certification to safety standards for medical devices, equipment calibration, ISO 17025 Guidelines Accreditation, and International Regulations etc.).

• Direct experience with interacting with NRTL’s (i.e, UL, CSA, etc)

• Experience interacting with regulatory agencies and participating in audits.

• Possess excellent verbal and written communication skills as well as interpersonal skills necessary to work across multiple engineering disciplines, and project management.

• Ability to work independently & proven proficiency in project management, problem solving, and MS Office tools (Word, PowerPoint, etc.)

• Direct experience with global product safety and EMC standards (e.g. IEC 60601-1 and IEC 60601-1-2 and Collateral and Particular standards for ventilators, sleep apnea devices, oxygen concentrators etc.)

• Experience and knowledge in Bio-Safety Level 2 Lab Operations is a plus.

• Experience with wireless compliance standards is a plus.

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.