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Software Quality Engineer

3 months ago

Lafayette, United States LanceSoft, Inc. Full time

Job title: Software Quality Engineer

Location: Lafayette, Colorado

Duration: 06+ months Contract


Top Skills:

1. Risk management: experience in assessing and mitigating risks associated with SW development in medical devices following ISO 14971.

2. Software development life cycle (SDLC): experience in SDLC for medical device, or highly regulated industry.

3. SW verification and validation: experience in testing methodologies.

Job Description:

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.

• Define appropriate measures to ensure software quality.

• Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development strategies, risk management, and verification and validation test approaches.

• Support Software New Product Development, Design Control, and Design Transfer processes, as well as responsibility for Quality deliverables during product development.

• Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files.

• Identify and implement software process metrics for the software product development lifecycle

• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

• Follow all Quality System Practices as defined by Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.