Software Quality Engineer

Software Quality Engineer – Medical Devices

12-Month Contract | Fully Remote | 40+ Hours per Week

Immediate start

Maclivaro is working with a large, national medical device and biologics company seeking an experienced Software Quality Engineer to support software quality, compliance, and verification and validation activities across medical device products.

This is a quality-focused role, not a software development position. We are looking for someone with hands-on experience working on the software of medical devices, who can review software code, assess software verification and validation activities, and ensure compliance with relevant FDA regulations and quality requirements.

The successful candidate will work closely with software engineering, quality, and regulatory teams to ensure medical device software meets the required standards for safety, quality, and regulatory compliance.

Key Responsibilities

• Review software code from a quality and compliance perspective, identifying potential risks, gaps, and issues.
• Review and assess software verification and validation activities for medical devices.
• Evaluate software documentation, test protocols, test results, and traceability to ensure compliance with applicable FDA requirements.
• Ensure software development and lifecycle activities align with relevant medical device regulations and standards.
• Support software quality reviews, risk assessments, deviation investigations, and CAPA activities where required.
• Work collaboratively with software engineers, Quality Assurance, Regulatory Affairs, and other cross-functional teams.
• Identify compliance gaps and support the implementation of appropriate corrective actions.
• Ensure software-related documentation and evidence are suitable for regulatory inspection and audit.

Essential Experience

• Proven experience in a Software Quality Engineer or equivalent quality-focused role within the medical device industry .
• Hands-on experience working with medical device software and software quality assurance.
• Ability to read and understand software code, assess code reviews, and identify potential quality or compliance concerns.
• Experience reviewing software verification and validation documentation, protocols, and results.
• Strong understanding of FDA requirements relating to medical device software.
• Experience working within regulated medical device quality management systems.
• Strong documentation, analytical, and problem-solving skills.

Desirable Experience

• Experience working with medical imaging equipment, particularly hospital X-ray machines, CT scanners, or other large-scale diagnostic imaging systems.
• Familiarity with relevant medical device software standards, such as IEC 62304, ISO 13485, and ISO 14971.

Experience with medical imaging systems would be a significant advantage, but is not essential.

Contract Details

• Contract length: 12 months
• Hours: 40+ hours per week
• Location: Fully remote
• Industry: Medical Devices / Biologics
• Engagement: Contract

Interested?

If you have a strong background in medical device software quality, can confidently review software code and verification and validation evidence, and understand the regulatory requirements for bringing safe and compliant medical devices to market, we'd love to hear from you.

Please get in touch with Maclivaro to discuss the opportunity in more detail.