Quality Engineer-Medical Device

Schedule:

Sunday through Thursday, 10:00 PM to 6:30 AM
Some overtime may be required.

The Quality Engineer I will support software development quality and compliance activities within a regulated environment. This role will work cross functionally with engineering, manufacturing, quality, information management, and product performance teams to ensure software development activities meet established procedures and industry regulations. The position will support lifecycle deliverable reviews, hazard analysis, testing, documentation, and training activities.

• Consult with cross functional teams to ensure compliance with software development procedures and applicable industry regulations.
• Review and approve deliverables throughout the software development lifecycle.
• Lead teams in performing hazard analysis activities to identify and address potential product and process risks.
• Support the development and revision of Standard Operating Procedures and Work Instructions for software development activities.
• Write and execute test protocols and prepare associated test reports as needed.
• Provide training on select software development activities and procedures.
• Collaborate with engineering, quality, manufacturing, information management, and product performance teams to support compliance and quality objectives.
• Contribute to documentation and continuous improvement activities within the software development process.

• Bachelor's degree in Engineering or a related technical discipline, or an equivalent combination of education and experience.
• Zero to three years of experience in an engineering, quality, software development, or regulated technical environment.
• Understanding of software development lifecycle processes and quality practices.
• Experience reviewing technical documentation and working with established procedures.
• Strong analytical, problem solving, documentation, and cross functional communication skills.

• Experience working in a regulated healthcare, medical device, diagnostics, or life sciences environment.
• Familiarity with risk management and hazard analysis methodologies.
• Experience developing or executing test protocols and preparing technical reports.
• Familiarity with Standard Operating Procedures and Work Instructions.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.