Senior Quality Assurance Engineer
My client is looking for a Senior QA Engineer who will focus primarily on the quality management of electro/mechanical medical devices.
You will have the opportunity to learn and progress within the large portfolio of devices within this company including medical device software products.
In general,this position will be accountable for concurrent quality engineering activities associated with new product development, risk management, conformity to applicable quality management systems and the clients requirements for instrument hardware and software. Primary responsibility will be to handle quality engineering duties in the following areas: design controls, risk management, previous product analysis, change control, post market review, quality planning, continuous improvement and establishment of appropriate requirements management and traceability.
- Participate in new product development projects by providing quality engineering support for assigned projects.
- Ensure engineering and scientific analyses are employed and design history files comply with company policies and applicable standards and regulations.
- Key deliverables include, but are not limited to performing previous product analysis on similar products and risk management activities. Supporting project team activities for requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
- Facilitating Risk Management activities according to company policy, procedures and ISO 14971, including Risk Management Planning, Risk Analysis, Risk Management Reporting and maintaining Risk Management File.
- Monitor Issue Databases to identify product quality trends and translate this information into improved product designs.
- Facilitate and participate in Root Cause Analysis of identified product and process deficiencies initiating system corrective actions as required.
- Monitor, review and update product development practices and associated documentation to ensure conformity to regulatory requirements and provide continuous improvements with the aim to increase product quality to the clients customers.
If you would like to work on a brand new site in a newly developed team focussing on the design of a varied portfolio of products as well as having full training provided to beome versatile within this role then please do apply now or e-mail me for more information at email@example.com