Senior Software Quality Engineer - Digital Products

ZipRecruiter; Manchester; On-site; GBP 80,000 - 100,000

Job description

About Sequel
Sequel Med Tech is an early-stage company developing the next of precision drug delivery devices.

Job Overview

We are seeking a highly skilled Senior Software Quality Engineer - Digital Products to join our Quality organization. Reporting to the Director of Quality, the Senior Software Quality Engineer will support quality efforts for the development and distribution of software product, including design and development as required and validation and verification efforts for the software components of Sequel’s medical device products. The ideal candidate will have extensive experience in software quality assurance within the medical device industry, ensuring compliance with applicable standards and regulations throughout the software development lifecycle.

Job Responsibilities and Essential Duties

• Provide quality engineering support for software project teams throughout the software lifecycle, from design through launch, ensuring integration of quality into software development, scientific computation, and data acquisition functions.
• Ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, and IEC 62304 standards.
• Develop and maintain software quality assurance plans, including risk management and validation strategies, to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams, including software development, regulatory affairs, and clinical teams, to ensure alignment on quality objectives and regulatory expectations.
• Participate in design reviews, code reviews, and other technical assessments to identify potential quality and compliance issues early in the development process.
• Conduct audits and assessments of software development processes and deliverables to ensure adherence to internal procedures and regulatory standards.
• Provide guidance and training to software development teams on best practices for software quality assurance and regulatory compliance.
• Lead the investigation and resolution of software-related quality issues, including root cause analysis and implementation of corrective and preventive actions.
• Stay current with evolving regulatory requirements and industry best practices related to software quality assurance and medical device software development.
• Partner with QA team on software quality documentation.
• Work closely with the software engineering team to implement and maintain a robust software quality management system.
• Follow agile practices in the development of medical software products, including TIR45, PCCP, or other models for agile software compliance.
• Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks.

Minimum Requirements

• 5+ years' experience in software quality engineering within the medical device industry.

Required Knowledge, Skills and Abilities

• Strong understanding of FDA regulations, ISO 13485, IEC 62304, and 21 CFR Part 11.
• Experience with risk management processes and tools, including FMEA and fault tree analysis.
• Proven ability to work effectively in cross-functional teams and communicate complex quality and regulatory concepts to diverse stakeholders.
• Excellent problem-solving skills and attention to detail, with a proactive approach to identifying and addressing potential quality issues.
• Certification in quality engineering (e.g., ASQ CQE) is a plus.
• Experience in a startup or fast-paced environment is a plus.