Software Quality Engr II - Exempt

Join our dynamic team in Lafayette, CO, where innovation meets quality. We are seeking a Software Quality Engineer to support both Medical Device software development and commercially available software products. This hybrid role offers the opportunity to work onsite four days a week, collaborating with cross-functional teams to ensure the highest standards of software quality and compliance., Responsibilities may include the following and other duties may be assigned:

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
• Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
• Define appropriate measures to ensure product quality.
• Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
• Ensure that projects and process control documentation are compliant with requirements and objectives.
• Review software systems design, change specifications, and plans against contractual and/or process requirements.
• Provide or direct verification and validation of software system requirements, traceability, and testability., Description : Duties: Performs a variety of systems administration and support tasks, including monitoring, analyzing, reporting and tracking, auditing, constructing, documenti…
• 1 month ago +

• Expertise in computer and software validation and change control of Medical Devices.
• Understanding of medical device regulations, including EU MDR, ISO 13485, and IEC 62304, and the ability to keep devices compliant with evolving regulations.
• Experience with non-medical product development processes and lifecycle requirements.
• Ability to serve as the voice of the Software Systems function, providing guidance from a software and systems perspective.
• Expertise in training development and delivery.
• Broad understanding of medical device development, regulation, and approval in the EU and US.
• Familiarity with emerging AI-related standards and requirements.
• Expert-level process development skills for creating quality system documents for diverse users and product types.
• Advanced understanding of design controls, quality system regulations, and failure investigation methodologies.
• Ability to apply design control principles and quality engineering techniques throughout the product development process.
• Proficiency in defect analysis and the design and implementation of quality testing and validation tools.
• Experience in developing and implementing processes and procedures.

Nice to Have:

• 0-3 years of medical/clinical experience or exposure.
• 2 years of Medical Device experience.
• Experience with Agile QMS and Cloud Based Software.
• Knowledge of NC/CAPA., * Bachelor’s degree required.
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Be a part of our team and contribute to the development of cutting-edge medical device software in a collaborative and innovative environment in Lafayette, CO.

• Lafayette, LA About Our Company: At Infinx, we’re a fast-growing company focused on delivering innovative technology solutions to meet our clients’ needs. We partner with healthcare providers t…

• 8 days ago