Medical Device QA Engineer

CAPA, Medical Device industry, Root Cause Analysis, SW/HW QA
Full Time
Depends on Experience
Travel not required

Job Description

In this position you will, Secure and support compliance with Quality Standards. Integrate and harmonize site specific processes into Quality System. Develop relevant processes with the departments. Provide Quality Engineering support for software and hardware development projects. Maintain and improve the Customer satisfaction process, including Complaint Handling, Corrective and Preventive Action, Data Analysis and Quality Reports.You will, be responsible for all relevant QA tasks at the site with a strong focus on product and software development and customer satisfaction. Support development teams in using effective methods and processes for design, verification and validation of hardware and software products, including reviewing the project toll gate deliverables and design reviews. Lead the Customer Complaint Handling Process, CDT&R Process (Customer Defect Tracking & Resolution Process) and CAPA process, including Root Cause Analysis and corrective and preventive actions. For that a close team work with Service and Sales is required. Work together with the Site Management and Corporate QM department to integrate this site into the Corporate Quality Management System. This will be a first project and includes gap analysis, defining action plans, creating relevant process descriptions, training and supporting audits. Prepare regularly performance evaluations and data analysis for the RA/QA KPIs, including Trend charts, Pareto Diagram and further supportive analysis. Maintain and proceed all relevant RA/QA tasks, e.g. Promotional Material Reviews, Audits, QA Trainings.

  • A Bachelor's degree in Engineering, Software Engineering or a related field is required. A Master's degree is preferred.
  • Experience in software development process and product development processes.
  • Knowledge in Quality Management System ISO 9001, preferred also ISO 13485
  • Demonstrated understanding or aptitude to understand regulatory requirements
  • Experience in CAPA Handling, Root Cause Analysis and Complaint Handling is preferred.

"We Engineer your success" Britech Group, Inc is a Technology Staffing Company who are experts in integrating exceptional people with top companies. Additional Job Openings-

Dice Id : 10118384
Position Id : Req-1708
Originally Posted : 4 months ago
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