Manufacturing Quality Engineer

2 weeks ago

Bothell, United States Philips Full time

JOB DESCRIPTION

Job Title

Job Description

In this role, you will have the opportunity to be a Quality Engineer supporting manufacturing in the Emergency Care - Home and Public (EC-HP) business. This position holder will be responsible for leadership in the manufacturing area ensuring that products are made to business and customer expectations.

Working in the medical industry brings much fulfillment, as well as unique challenges.

As part of our HealthTech – focused company, you will be responsible for successfully managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

In this role, you are responsible for:

- Driving quality in manufacturing

- Participating in risk management activities

- Assisting with the transfer of designs into manufacturing

- Performing independent technical assessment on engineering or production deliverables

- Leading quality related problem solving and root cause analysis during manufacturing including CAPA

- Engaging with production teams to manage non-conforming product and to drive cost of non-quality reductions

- Using applicable data sources and statistics to report on product quality performance and taking action in accordance with data

- Ensuring that quality and compliance standards and regulations are met

You're the right fit if you have a customer-first attitude and the following:

- Bachelor’s Degree in Engineering or other relevant technical disciplines

- 5+ years of experience working in medical device industry, or 7+ years working in regulated industry

- Demonstrated experience directly working with at least one of the following areas: CAPA, Non-Conforming Product, Design Transfer.

- Deep understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, leadership, training, interpersonal relationships, improvement systems, and professional ethics

- Understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements

- Ability to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving

- Ability to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems

- ASQ Quality Engineer Certification is a plus

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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Manufacturing Quality Engineer