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Carestream is a worldwide provider of medical imaging systems and solutions; x-ray imaging systems for non-destructive testing; manufacturing of film and precision contract coating services for a wide range of industrial, medical, electronic and other applications-all backed by a global service and support network. Carestream's diagnostic imaging technology systems are at work in 90 percent of hospitals worldwide.
At Carestream, we offer a global perspective and a world of opportunities for people who have the desire to make a positive impact. Join our global team of 3,000+ professionals!
Compensation range of $80,000 to $95,000 annually.
*This range reflects Carestream's good faith estimate to pay fairly as starting wage. Offers will be tailored within the range based on the selected candidate's experience, industry knowledge, technical and communication skills, and other factors that may prove relevant during the interview process, as well as geographic market differentials for the position.
Carestream Health has an opening for an experienced Manufacturing Quality Engineer located 100% onsite at its DR manufacturing plant at 1049 West Ridge Road, Rochester, NY.
* Performs quality assurance activities in support of the Manufacturing organization
* Work with new product development teams in regard to manufacturing quality requirements, regulatory requirements, product hazard risk analysis, etc.
* Leading cross-functional corrective action team(s) when needed
* Leads root cause analysis activities
* Leads FMEAs, as needed
* Provides statistical analysis of production processes
* Creates and executes process validation/verifications and/or manufacturing quality plans
* Develop schedules/resource plans for validation/verification activities of a project
* Document and deliver to the appropriate repository all verification/validation results, analysis and test summary reports
* Comply with all SOP's that apply to their job function
* Represent customer perspective in project quality decisions
* Duties may include testing assignments on updates to existing products
* Duties may include activities to support the customer complaint process
* Duties may include supplier quality and audit activities
* Proactively drive quality process improvements
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Bachelor's degree in an engineering discipline or equivalent work experience
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3+ years of demonstrated engineering skills
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Experience with FDA regulated medical equipment manufacturing
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Process Validation / Verification planning, execution, and reporting experience
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Demonstrated data-driven decision making
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Leadership
* Six Sigma Black Belt or Green Belt Certification
* ASQ Certification
* Working knowledge of IS0 13485 requirements
* Familiar with Material Review Board process
Production Floor, Office
Standing: 1-25%
Walking: 1-25%
Sitting: 25-50%
Bending: 1-25%
Lifting up to 20 pounds: 1-25%
Lifting 20-35 pounds: 1-25%
Lifting 35-50 pounds: 0%
Carestream is an Equal Opportunity Employer
Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Applying for a job with Carestream
All applicants must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations
Requisition ID: 3866