Quality Engineer Medical Device Jobs in Raleigh, NC

Itron is innovating new ways for utilities and cities to manage energy and water. We create a more resourceful world to protect essential resources for today and tomorrow. Join us.

The Principal Quality Engineer is working in close collaboration with NPI core development teams and is thereforelocatedin R&D CentersOfExcellence.In order to achieve BL project success, the Project Quality Engineer ensures that the Itron Development Process is properly applied, manages global project risks and supports the PMO on all quality aspects, targeting "built in Quality" for new products and solutions.

• Coach Program/Project managers on Itron Product Life Cycle (PLC) activity for New Product Introduction (NPI) implementation and identify / manage gaps

• Challenge Itron Product Life Cycle (PLC) deliverables content (completed andvalidatedby competent people)

• Support / challenge the Project/Program manager for quality topics

• Verify readiness of project gates

• Validate project termination when the product and processes are capable in all domains (Design, Procurement, manufacturing, Sales, etc.)

• Lead Quality in project phases (problem solving, risk avoidance, phase reviews, product & processcapabilitiesand Lessons learned)

• Globally managing the project risks, ensure proper focus on contingency plans

• Represent customer voice in the project, manage customer in case of quality issues during the project phase

• Lead orparticipatein System FMEA (Failure Mode Evaluation and Analysis), Design FMEA and support Process FMEA, as well as any activity related to risk avoidance

• Support Supplier Quality in supplier selection EVAL/process audit along with PPAP's (Product Part Approval Process) & PVL's (Product Vendor Listing)

• Support /facilitateProject QRQC (Quick Reaction Quality Collaboration) and visual planning deployment

• Support interfaces with customers on Quality aspects during project phases when project is dedicated to a specific Customer

• Quality core team member in support of factory quality or in projects involving a 3rd party partner

• Initiate project Red Alert whenappropriateand ensure problem solving activities areproperly managed

• Manage project quality KPIs, analyze results and propose roadmap for improvement

• Interface with the Quality organization

• Ensure the quality network is properly informed about the project and the quality expectations

• Raise request for support to quality network when needed and when keys steps are not respected

• Insurethe Customer voice is well taken in account with Customer quality

• BachelorsDegree in Engineeringor a Science related field

• 8+ years of experience as a Quality Engineer or equivalent experience.

• Expert with Quality Tools such as FMEAs, 8Ds, quality plans, etc.

• Strong knowledge of reliability, capability, Design for capability (DesignForSix Sigma), SPC (statistical process control)

• Proficiency with Lean Development concepts

• Ability to review open issues, bugs, and requirements in Azure DevOps (ADS)

• Masters or MBA desired

Trevel: 0-10%

Benefits Info:

This position also includes a competitive benefit package including; financial, social, health and wellbeing programs, paid vacation, 401k matching, employee stock purchase program, hybrid work schedule, and more! This position is eligible for our 10% annual bonus program.

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Itron is committed to building an inclusive and diverse workforce and providing an authentic workplace experience for all employees. If you are excited about this role but your past experiences don't perfectly align with every requirement, we encourage you to apply anyway. In the end, you may be just who we are looking for!
The successful candidate's starting wage will be determined based on permissible, non-discriminatory factors such as skills and experience.
Itron is proud to be an Equal Opportunity Employer. If you require an accommodation to apply, please contact a recruiting representative at 1-800-635-5461 or email Accessibility@itron.com.

Itron is transforming how the world manages energy, water and city services. Our trusted intelligent infrastructure solutions help utilities and cities improve efficiency, build resilience and deliver safe, reliable and affordable service. With edge intelligence, we connect people, data insights and devices so communities can better manage the essential resources they rely on to live. Join us as we create a more resourceful world: www.itron.com