Your role:
- Ensure that appropriate quality plans are made that include all stages of the lifecycle of the product and support Quality plan design. Validate key design inputs, such as: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
- Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle.
- Perform independent technical assessment on product quality performance and post-market product quality analysis. Lead quality related problem solving and root cause analysis during design and manufacturing.
- Create and use post-market analytics, statistics and deliverables to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required.
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone. Execute risk management activities, biocompatibility testing, product failure rate and reliability estimations.
You're the right fit if:
- You’ve acquired 3+ years of Quality Engineering experience in a regulated environment, preferably within medical device.
- Your skills include:
- Independently produce and complete Quality Engineering documents.
- Develop and administer quality-related project plans and schedules.
- Perform timely, quality engineering tasks such as: assessing quality plans and product designs, reviewing test and other performance data, analyzing market feedback, and leading root cause analysis and quality problem solving.
- You have a bachelor’s degree in a scientific discipline; Engineering preferred.
- Quality Engineering or Quality Reliability Engineer certification, nice to have.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
- You excel in working on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. You’re proficient in following processes and operational policies in selecting methods and techniques for obtaining solutions.
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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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .
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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
be provided for this position. For this position, you must reside inwithin commuting distance to Bothell, WA.