Quality Engineer (Medical Device) - Intellectt INC
Irvine, CA
About the Job
Hello Everyone,
Greetings of the day.
This is Vydehi from Intellectt Inc. We currently have an opening for a Quality Engineer III with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to or reach out to me directly at +1 732 355 7412.
Role: Quality Engineer III
Location: Mansfield, MA
Duration: 12 Months
Primary responsibilities are to:
EUMDR Class II & III Compliance Projects
Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities.
Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Conduct benchmarking to develop more effective methods for improving quality.
Approve IQ, OQ, PQ, TMV or Software Validations.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
EUMDR Class II & III Compliance Projects
Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities.
Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Conduct benchmarking to develop more effective methods for improving quality.
Approve IQ, OQ, PQ, TMV or Software Validations.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
DESIRED MINIMUM QUALIFICATIONS
Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience
This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with a proven track record of implementing appropriate risk mitigation.
Good technical understanding of manufacturing equipment and processes is required.
Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience
This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with a proven track record of implementing appropriate risk mitigation.
Good technical understanding of manufacturing equipment and processes is required.
Source : Intellectt INC
