Quality Engineer

Quality Engineer

There are two positions. One in Milpitas, CA and one in Santa Ana, CA. Max. salary: 95K. Medical Devices Industry Experience is MUST (Pharma Exp. will NOT Help). Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards. Graduation: Mechanical / Production / Electronics / Bio Medical Engg (Bio-Chemistry / Chemistry or any other Science graduation will NOT work).

Relevant Experience(in Yrs) - 6+ years. Technical/Functional Skills - Coordinate design assurance activities in support of product development and life cycle processes between customer team and offshore team. Demonstrated experience with formal problem-solving methodologies. 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. ASQ Certification as a Quality Engineer is preferred.

Experience Required - Project management experience is required. Minimum (10 years) of Quality experience in medical device industry. Certified Six Sigma (Black Belt) is preferred.

Roles & 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.

Generic Managerial Skills - Must have strong organizational, analytical and problem-solving skills. Must have keen time management skills. Ability to work in a team proactively, flexibly in an environment.

Education - BS or MS degree (Mechanical, Biomedical Engineering, or related technical field).

Startdate(dd-mmm-yy) - 1-Feb-2018. Duration of assignment(in Months) - 12 months. Work Location(State, City and Zip) - 1 in Milpitas, CA and 1 in Santa Ana, CA. Client Billing Rate$/hr - 80. Rates payable to vendor$/hr - 60-65.