Software Quality Engineer II

Job Title: Software Quality Engineer II 

Location: Lafayette, CO 80026

Pay Rate: $50 – $55/hr on W2

Job Description

• This will be a Quality Engineering role supporting both Medical Device software development and commercially available software product with the team supporting that software. 
• This role will require cross-functional interaction with R/D and Quality to implement and provide process and procedural support. 

Top 3 technical skills that are required for the role:

• Design Quality Engineering IEC 62304
• QMS Process and Procedure
• Cloud Based Software Support

Education Required: Bachelor’s degree

Years’ Experience Required: 2 years or greater

Must Have:

• Computer and software validation
• Change control of Medical Devices
• Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations.
• Understanding of non-medical product development processes and lifecycle requirements.
• Serve as the voice of the Software Systems function on deliverables, providing guidance to cross-functional team members from a software and systems perspective.
• Expertise in training development and delivery.
• Broad understanding of how medical devices are developed, regulated, and approved in the European Union and the United States.
• Familiarity with, or the ability to quickly learn, evolving medical device regulations, including emerging AI-related standards and requirements.
• Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications.
• a Design Quality Engineer
• Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
• Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
• Can provide instruction and guidance of processes and procedures defect analysis skills design and implementation of quality testing and validation tools development and implementation of processes and procedures
• SaMD

Nice To Have

• 0-3 years of medical/clinical experience or exposure
• 2 years Medical Device experience
• Agile QMS
• Experience in Cloud Based Software
• NC/CAPA

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.