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