Services & Solutions Quality Engineer
1 maand geleden
You lead the quality and reliability activities during the development of new services and solution offerings including software platforms and its applications created by the Philips MR Services and Solution Delivery organization.
You ensure safe, effective & reliable services and solutions by design and deliver the highest quality and outstanding customer experience.
You use your expert Quality and Reliability engineering skills to provide coaching and support to the organization and assure that the quality targets are achieved. This involves being a confident advisor on quality and reliability engineering topics.
You are responsible for
Systematically design Quality and Compliance in all MR services and solutions offerings
Act as a single point of contact for project teams
Ensure that appropriate and actionable Quality plans are made that include all stages of the life cycle and support Quality plan design
Ensure validation of key Quality requirements like e.g. usability, reliability, performance, manufacturability, scalability, safety, security, privacy, serviceability, sustainability
Provide oversight via independent assessments on Serviced & Solutions Quality, Compliance and Risk Management activities throughout all phases of the project incl. post-launch monitoring phase using market or customer feedback
Facilitate data driven Design for Quality & Reliability best practices e.g. FMEAâs, V&V, PRIDE
Ensure Compliance strategic considerations and planning in the early stage of the services and solutions development and deployment for the Markets
Perform independently and timely execution of QMS operational processes (e.g. Management Review, CAPA, audit, change request, Quality plan)
Support the Supplier Quality teams to ensure adequate Quality plans are in place for 3rd party related activities
Monitor and continuously improve the S&S Quality and Compliance, reporting on a regular base and escalate where needed
You are the right fit if
Bachelorâs engineering degree with 8+ years of experience in Quality- or Reliability Engineering role in the medical, services and/or medical solutions industry
Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971
Certified Six Sigma greenbelt or blackbelt
Ability to contribute to Risk Management and Design FMEA activities and assurance that control measures are translated in appropriate requirements
Ability to define detailed Quality and Reliability plans for new services and solution developments to ensure those are safe, effective and reliable
Experience in application of Design Controls; ability to do thorough Design Reviews during new services & solution development to ensure robust designs
Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing  Â
Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes
Experience with adequate and accurate review of DHF and DMR documents
Experience with working in multidisciplinary teams in a high-tech R&D environment
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 the lives of others.
⢠Learn more about our business.
⢠Discover our rich and exciting history.
⢠Learn more about our purpose.
If youâre 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 here.
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