Quality Engineer-Medical Device

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

About the role

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.

Responsibilities

• 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.

Requirements

• 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.

Preferred Qualifications

• 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.

Benefits

• 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
• Paid vacation time
• Paid parental leave
• Paid holidays annually

Pay

$30/hr to $38/hr