Description
Quality Engineer - Software / ElectromechanicalThis position is responsible for providing Quality Assurance engineering support for all lifecycle phases of commercialized products. This individual will lead the Quality activities related to the New Product Development and necessary on-going activities to support the development and commercialization of an electromechanical product with embedded software.
Duties and Responsibilities:
- Support the new product introduction process and Design Control activities to ensure that new products meet customer requirements and specifications. Serve as subject matter expert for quality related issues for software and electromechanical products.
- Direct all activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, risk management, and performance.
- Support product qualifications / testing, write protocols / reports, create Quality plans etc.
- Software Quality Assurance engineering support for all lifecycle phases of commercialized software products. Provide interpretation and guidance on various Software Development Life Cycle methodologies.
- Ensure new product development is in compliance with specific medical device regulations for software and electrical safety such as ISO 62304, ISO 60601 etc.
- Support Corrective and Preventive Actions, internal / external audits, NCR resolution department and other quality improvement initiatives
Knowledge/Skills/Abilities:
- Working experience with quality systems, FDA Quality System Regulation and ISO 13485
- Strong working knowledge of various Software Development Life Cycle (SDLC) models and software risk analysis
- Test methods and concepts exposure including: exploratory testing, regression, stress and load testing, and black-box and white-box testing
Experience/Education:
- Bachelor's degree in Computer Science, Electrical Engineering, mechanical /biomedical engineering related field or equivalent education and experience
- Min 5 years experience in quality assurance or engineering in medical device (preferred), bio-tech or other highly regulated or process-driven environments (e.g. aerospace, defense)
- Proven experience in Software Quality Assurance and/or Software Testing.