Quality Engineer jobs in United States
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Kimball Electronics · 1 day ago

Quality Engineer

Kimball Electronics is a Medical Device Contract Manufacturer based in Indianapolis, IN, seeking a Quality Engineer to oversee customer quality metrics and ensure product integrity. The role involves direct customer communication, data-driven decision making, and collaboration with other functions to resolve quality issues.

ElectronicsManufacturing
badNo H1Bnote

Responsibilities

Learn KEIND Quality System requirements
Learn Customer Requirements and Quality flow downs
Take co-ownership of the customer meetings, data for the meetings, action items
Learn Quality and Manufacturing documentation and processes
Learn and provide input to the NCR and NPI process
Learn and adopt Kimball Electronics philosophies and culture
Co-own Corrective Actions to closure
Reduce overall customer PPM and improve internal yields
Implement data-driven actions/poke yokes to improve customer metrics
Help investigate customer RMA's and communications of complaints
Participate in customer supplier audits
Review customer documentation and determine process/flow and equipment/tooling requirements
Work with Quality Department to improve the efficiency of inspection methods/processes through improved methods, improved manufacturing processes, and identification of resource needs
Train others on quality related requirements, procedures and methods
Implement corrective actions in place to eliminate the failure modes
Analyze quality data and identify trends
Document implement new processes while improving current processes and documentation
Improve your product, processes, yourself and your customer team
Guide processes and documentation for NPI production assembly and ECN requirements and maintain revision control of products
Ensure products are designed for manufacturability (DFM) and work with Customer to implement DFM recommendations
Review customer documentation and determines process/flow and equipment/tooling requirements
Use material, equipment and personnel in producing quality products at minimum costs and help develop quotations in response to our customer's RFQs

Qualification

FDA knowledgeStatistical AnalysisQuality Systems knowledgeCAPARoot cause analysisDesign transfer processesQuality Control PlansSPC knowledgeProblem solving techniquesCommunication skillsTeam collaboration

Required

FDA or Life Sciences related industry background with + years of experience in medical device, molding and related technology
Use Statistical Analysis and Tools
Chi Square, ANOVA, DOE, SPC
ESD knowledge, GD&T knowledge, MSA knowledge
Quality Systems knowledge and International Standards (ISO 13485)
Experience with Quality Control Plans, PFMEAs and PPAP Requirements
CAPA and root cause analysis background
Experience writing quality procedures and a having a disciplined problem solving approach
Experience in Design transfer processes for new product launches
Problem solving techniques and processes

Benefits

3 weeks of PTO starting your 1st year
10 paid holidays
Major health, dental, vision, and complementary insurances starting day 1
50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually

Company

Kimball Electronics

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Kimball Electronics is an electronics manufacturer.