Quality Engineer I – Regulated Software (Night Shift)

Collabera Inc.; Scarborough, Northern (ME, KY); Hybrid; USD 41,000 - 52,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Life Insurance

Long-term Disability Insurance

Paid Parking/Public Transportation

Paid Time Off

Paid Sick and Safe Time

Paid Vacation Time

Paid Parental Leave

Paid Holidays

Job summary

Collabera Inc. seeks a Quality Engineer I to support software development quality and compliance in a regulated environment.

The role will coordinate with engineering, manufacturing, quality, information management, and product performance teams to ensure processes meet procedures and regulations. You will participate in lifecycle deliverable reviews, hazard analysis, testing, documentation, and training activities, while contributing to risk assessment and continuous improvement of software

Qualifications

• Bachelor's degree in Engineering or related technical field or equivalent experience.
• Zero to three years of experience in engineering, quality, software development, or regulated environments.
• Understanding of software development lifecycle and quality practices.
• Experience reviewing technical documentation and following established procedures.
• Strong analytical, problem solving, documentation, and cross functional communication skills.

Responsibilities

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

Skills

Cross-functional communication

Analytical thinking

Documentation

Problem solving

Quality mindset

Regulatory awareness

Education

Bachelor's degree in Engineering or related

Job description

Collabera Inc. seeks a Quality Engineer I to support software development quality and compliance in a regulated environment.

The role will coordinate with engineering, manufacturing, quality, information management, and product performance teams to ensure processes meet procedures and regulations. You will participate in lifecycle deliverable reviews, hazard analysis, testing, documentation, and training activities, while contributing to risk assessment and continuous improvement of software