Tephra Inc.
Design Control & Quality Systems Engineer
Tephra Inc., Milpitas, CA
Description:
Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team
• Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards
• Advanced 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:
• Responsible for developing/updating quality plan
• Prepare, execute, review and approve design verification test protocols and reports
• Determine statistically relevant sample sizes
• Able to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report
• Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
• Investigate, identify and implement corrective and or preventive actions to close design control CAPAs
• Assess design control procedure updates and determine product and business impact
• Lead projects related to major design control upgrades
• Engaging with project teams to gather and incorporate feedback to improve design control
• Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
• Work with manufacturing engineer/process engineer to ensure necessary process controls are in place
• Work with manufacturing engineer/process engineer during process validation execution and protocol and report review and approval
• Assess 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
Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team
• Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards
• Advanced 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:
• Responsible for developing/updating quality plan
• Prepare, execute, review and approve design verification test protocols and reports
• Determine statistically relevant sample sizes
• Able to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report
• Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
• Investigate, identify and implement corrective and or preventive actions to close design control CAPAs
• Assess design control procedure updates and determine product and business impact
• Lead projects related to major design control upgrades
• Engaging with project teams to gather and incorporate feedback to improve design control
• Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
• Work with manufacturing engineer/process engineer to ensure necessary process controls are in place
• Work with manufacturing engineer/process engineer during process validation execution and protocol and report review and approval
• Assess 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