Design Control & Quality Systems Engineer
Description:
Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team oGood Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards oAdvanced Technical Training in Quality Engineering principles, Risk Management, Ophthalmic Sciences and Technology, Systems Engineering and/or Process Excellence (Certified Six Sigma Black Belt) is preferred
Responsibilities:
oResponsible for developing/updating quality plan oPrepare, execute, review and approve design verification test protocols and reports oDetermine statistically relevant sample sizes oAble to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report oCreating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes oInvestigate, identify and implement corrective and or preventive actions to close design control CAPAs oAssess design control procedure updates and determine product and business impact oLead projects related to major design control upgrades oEngaging with project teams to gather and incorporate feedback to improve design control oPrepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
oWork with manufacturing engineer/process engineer to ensure necessary process controls are in place oWork with manufacturing engineer/process engineer during process validation execution and protocol and report review and approval oAssess impact of validations on SOPs, process sheets, FMEAs and Quality Control Plans
Qualifications:
o BS or MS degree (Mechanical, Biomedical Engineering, or related technical field) o Project management experience is required o Minimum (6-8 years) of Quality experience in medical device industry o ASQ Certification as a Quality Engineer is preferred Recommended Skills Biomedical Engineering Cost Benefit Analysis Design Assurance Design Verification Test Failure Mode Effects Analysis Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team oGood Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards oAdvanced Technical Training in Quality Engineering principles, Risk Management, Ophthalmic Sciences and Technology, Systems Engineering and/or Process Excellence (Certified Six Sigma Black Belt) is preferred
Responsibilities:
oResponsible for developing/updating quality plan oPrepare, execute, review and approve design verification test protocols and reports oDetermine statistically relevant sample sizes oAble to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report oCreating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes oInvestigate, identify and implement corrective and or preventive actions to close design control CAPAs oAssess design control procedure updates and determine product and business impact oLead projects related to major design control upgrades oEngaging with project teams to gather and incorporate feedback to improve design control oPrepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
oWork with manufacturing engineer/process engineer to ensure necessary process controls are in place oWork with manufacturing engineer/process engineer during process validation execution and protocol and report review and approval oAssess impact of validations on SOPs, process sheets, FMEAs and Quality Control Plans
Qualifications:
o BS or MS degree (Mechanical, Biomedical Engineering, or related technical field) o Project management experience is required o Minimum (6-8 years) of Quality experience in medical device industry o ASQ Certification as a Quality Engineer is preferred Recommended Skills Biomedical Engineering Cost Benefit Analysis Design Assurance Design Verification Test Failure Mode Effects Analysis Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
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