Job details
Salary $40 - $60 an hour job type full-time contract number of hires for this role 1
Qualifications
Bachelor`s (required)
Full job description
Exciting opportunity to join a team preparing product for eumdr submissionProvide engineering expertise in support of supplier quality process improvement and activities in support of successful eumdr certification.
The supplier quality engineer will report to the site quality manager
Position responsibilities:
Works in conjunction with project manager, r&d, design assurance engineers, quality, regulatory, and others functions to assist engineering team in identification, planning, execution, implementation, and monitoring of eumdr preparation activities.
Coordinate resources, from various departments, to resolve issues and implement changes.
Lead and/or participate in changes to product specifications, and part quality risk assessments as appropriate to support eu mdr regulations and quality objectives.
Creates bills of material at the subassembly and product level.
Interface with external suppliers including management of supplier corrective actions to achieve rohs, reach and cal prop 65 compliance.
Reviews and updates hazard analysis, dfmea and pfmea to support eu mdr regulations and quality objectives.
Provide tactical process improvement and change management support to internal processes and external suppliers in resolving quality, productivity, and routine technical issues related to existing products.
This person will also ensure that product is manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirementsIn the case where corrective action is needed, this person will lead mitigation activities.
Creates and maintains the documentation necessary to ensure the consistent supply of products and components ).
Interfaces with manufacturing engineering and research and development organizations to integrate new drawings, specifications or processes into the existing supplier base
Lead efforts to transfer products to new suppliers
Comply with applicable fda and international regulatory laws/standards and the medtronic code of conduct.
Other responsibilities as assigned or required to ensure project success.
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Qualifications*
Bs degree and 3-6 years of medical device experience or 2-6 years with an applicable ms degree
Leading/participating in changes to product specifications, and part quality risk assessmentsThis ties with experience with hazard analysis and dfmeas.
Creation of bills of material at the subassembly and product level.
Interfacing with external suppliers including management of supplier corrective actions to achieve rohs, reach and cal prop 65 compliance.
Equal opportunity employer/veterans/disabled
To read our candidate privacy information statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The company will consider qualified applicants with arrest and conviction
Job types: full-time, contract
Pay: $40.00 - $60.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Referral program
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to friday
Education:
Bachelor`s (required)
Experience:
Supplier quality: 3 years (required)
Medical device: 3 years (required)
Work location: remote
