Senior Software Quality & Compliance Engineer

RXinsider LTD.; Burlington (MA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health benefits

Equal opportunity employer

Job summary

Abbott in the United States is seeking a Senior Software Design Assurance Engineer to support software development and apply quality engineering methods across design and validation. You will review software test protocols, development plans, and documentation, and lead risk assessments (e.g., FMEA) with cross‑functional teams.

The role emphasizes validation activities, cybersecurity considerations, and compliance with US FDA regulations.

Qualifications

• Bachelor’s degree in engineering or a technical field.
• Minimum of 5 years related work experience in Quality or a related field.
• Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Responsibilities

• Provides technical and quality system guides related to software requirements.
• Review software test protocols, development plans, and reports for approval.
• Leads meetings to prioritize actions addressing issues captured in problem resolution systems.
• Leads risk evaluation and mitigation including FMEA and product risk analysis.
• Participates in reviews to ensure software deliverables meet design outputs.
• Ensures non-product software validation needs are identified and documented.
• Supports cybersecurity assessments with cross-functional teams.
• Maintains compliance with FDA regulations and company policies.
• Develops training for personnel on software development and validation.
• Supports audits and quality system improvement initiatives.

Skills

Quality engineering

Risk assessment

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in engineering or a technical field

Advanced degree

Job description

Abbott in the United States is seeking a Senior Software Design Assurance Engineer to support software development and apply quality engineering methods across design and validation. You will review software test protocols, development plans, and documentation, and lead risk assessments (e.g., FMEA) with cross‑functional teams.

The role emphasizes validation activities, cybersecurity considerations, and compliance with US FDA regulations.