Description
Position DescriptionActivities focus on risk assessment documents to include, Health Hazard Analysis and End Product Risk Assessment, product and process engineering change risk assessment. CAPA (Corrective Action Preventive Action) support.
Position Responsibilities
* Work with responsible persons (from Released System Engineering, Supplier Quality Engineering, Manufacturing, and other business units) for product field performance and reliability issues.
* Assist root cause analysis for CAPA. Review CAPA Investigation Reports.
* Author HHA (Health Hazard Analysis), facilitate review and approved process with CAPA Board and REB (Risk Evaluation Board), and work with Marketing, Product Development, Quality Systems and Regulatory on field action plans.
* Work with Released Product System team in value engineering projects and design improvement projects, including FMEA (Failure Mode and Effect Analysis), Risk Assessment, DVT (Design Verification Test) and other engineering documents review.
* Review and approve changes to products in production for reliability impact to aid in the correction of process, design or materials problems.
* Support Materials Quality Assurance Engineering by providing reliability input in evaluation of discrepant material and in the validation of new material to assure that device reliability requirements are met. Support Regulatory Affairs by providing reliability input in the evaluation and submission of requests for approval to the FDA.
* Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work.
* Assist in the development of qualification plans, reports and validation of manufacturing processes.
* Predict inherent reliability of systems using appropriate statistical and reliability tools.
Basic Qualifications
BS Degree in Engineering and 5 years of engineering experience.
ISO 14791 experience
To find out more about Real please visit www.realstaffing.com