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: 

oBS or MS degree (Mechanical, Biomedical Engineering, or related technical field)

oProject management experience is required

oMinimum (6-8 years) of Quality experience in medical device industry

oASQ Certification as a Quality Engineer is preferred