Medical Device Quality Engineer - Software Development

Category:

Life Science

Employment Type:

Contract

Reference:

BH-385191

Summary

Ensures compliance to global and local Product Development Process procedures, through proper development and testing of product software. Ensures compliant transfer of product software to manufacturing according to established procedures to meet all quality requirements. Provides guidance to R&D teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.

Duties

1. Quality Engineering Support for product software Design Control Process -Implement/facilitate product risk management planning as needed. Facilitate and participate in product software design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary.
2. Leads risk management for R&D, including updating risk files based on customer complaint feedback, assessing risk of proposed changes, and performing risk analysis for R&D projects.
3. Serve as primary contact for assigned R&D projects and provide coaching / mentoring to project managers and/or product software development team in regard to the product development process, design control, risk assessment, etc.
4. Review and provide feedback on design documentation to support the product development process.
5. Participate in technical or specialty design review(s) for product development and participate as QA representative in the design change management process for product development.
6. Assists in the development, review, and execution of quality management system areas (e.g. change control, document control, risk analysis, design control, verification and validation, etc.).
7. Develop and/or edit standard operating procedures.
8. Contribute to maintain compliance to quality systems and programs in the areas of change management, design control, product verification and validation, initiating CAPAs for relevant design issues, etc, to ensure compliance with FDA and regulatory requirements.
9. Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.
10. Participates in CAPA activities, including investigation, effectiveness, and root cause analysis. Supports implementation of corrective actions and preventive measures.

1. Bachelor's degree in science related field - e.g. computer science, engineering, biology, etc
2. Requires a minimum of eight (8) years experience in a related industry regulated by FDA.
3. Requires demonstrated competence in software development processes, good practices, and demonstrates ability to appropriately select and apply quality engineering tools and techniques.
4. Experience applying risk management using ISO 14971
5. Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
6. Requires effective written and oral communication skills to interact across all levels of the organization.
7. Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).