General Information:
- Company: Bard Medical Division-TTM
- Title: Software Quality Assuarance Engineer
- Job id: 2013-6861
Overview:
- Provide quality software engineering support in design and development of medical device products, specifically, patient temperature management products.
- Responsible for performing various software quality assurance activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities.
- These activities include software life cycle management, design control & documentation, requirements engineering, test case engineering and coverage, configuration management, risk management, usability engineering, design verification and validation, process validation, failure analysis, corrective and preventive action, performing internal and supplier audits to verify compliance with ISO and FDA/QSR Regulations, supporting external audits, personnel training and hands-on software testing.
General Responsibilities:
- Develop, implement and maintain standards for software quality processes, systems and procedures to support the software life cycle
- Ensure that software project and process control documentation are compliant with established procedures
- Support Research and Development, Manufacturing, Production and IT in Software Quality Assurance
- Review product requirements for traceability, risk remediation and testability
- Review verification and validation deliverables for compliance with regulatory requirements
- Review software test harness / test cases for clarity and requirements coverage
- Preparation and analysis of periodic Quality Reports
- Perform internal and support external audits of products and processes
- Selection, qualification and monitoring of outside suppliers
- Preparation and review/approval of Engineering Changes and MRB Materials
- Collect, analyze and take action on performance measurement indices, statistical capability/ reliability analysis
- Enhance the Quality Management System in such areas as Design Review Process, Compliance to Standards, Change Management, Software BOM enhancements, and Device History File (HDF)
- Lead specific continuous improvements initiatives which will evolve into a more robust software quality assurance process. Track software problem reports and deviation up to closure
- Support the development , update, validation, and documentation of software utilized in the automated testing of printed circuit boards and finished medical devices
- Assist in maintaining, troubleshooting, and repairing software elements of automated test systems utilized in manufacturing and service
- Support IQ/OQ/PQ activities involving software based manufacturing and service equipment
Basic Qualifications
- Bachelor of Science Degree or equivalent experience
- 5 to 7 years experience testing medical device software as well as establishing and upholding software life cycle processes
- Demonstrate sense of good leadership style with the ability to act as change agent within organization
- Comfortable working in a software and hardware medium scale system level product environment with associated test equipment and cabling
- Strong organizational, time-management, verbal and written communication skills
Applying:
- For more information and to apply see job posting https://jobs-crbard.icims.com/jobs/6861/job
