At a Glance
- Tasks: Lead software quality initiatives for innovative medical and digital products.
- Company: Join Baxter, a leader in healthcare technology with a commitment to quality.
- Benefits: Enjoy competitive pay, health benefits, and opportunities for remote work.
- Other info: Collaborative culture with strong career growth potential.
- Why this job: Make a real difference in healthcare by ensuring high-quality software solutions.
- Qualifications: 10+ years in software quality engineering, especially in regulated environments.
The predicted salary is between 70000 - 90000 £ per year.
The Sr. Principal Engineer, Quality applies a deep and broad understanding of software engineering principles, quality engineering practices, and regulatory requirements to lead the continuous improvement of software-enabled medical and non‑medical products. This role spans regulated medical device software (e.g., IEC 62304) as well as non‑medical digital solutions, ensuring scalable, compliant, and high‑quality software delivery across diverse platforms. This role plans, executes, and functionally directs quality programs requiring independent judgment, technical authority, and cross‑functional leadership. The individual serves as a recognized technical expert in software quality, and Quality Management System (QMS) integration, ensuring alignment with ISO 13485 and EU MDR requirements while enabling modern software development practices.
Responsibilities
- Lead and govern activities that ensure alignment with Baxter’s Product Lifecycle Management (PDLM) and Change Control Management (CCM) processes and compliance with design controls and quality system regulations.
- Translate Agile software development practices into compliant frameworks that meet Baxter, ISO 13485 and EU MDR expectations, including traceability, documentation, verification, and validation.
- Ensure effective implementation of software design controls, including:
- Software requirements and architecture
- Risk management (software hazard analysis, cybersecurity risk)
- Verification and validation strategies (manual, automated, CI/CD pipelines)
- Configuration and change management
- Lead integration of Quality Management System (QMS) processes into software development workflows, including:
- CAPA and nonconformance handling
- Complaint handling and feedback loops into Agile backlogs
- Audit readiness and inspection support
- Ensure compliance with EU MDR requirements, including:
- Support for technical documentation and software lifecycle evidence
- Alignment of software changes with regulatory impact assessments
- Post‑market surveillance inputs (e.g., trending, signal detection)
- Apply advanced quality and engineering tools, including root cause analysis, reliability engineering, and data analytics, to improve software quality and system performance.
- Oversee development of technical documentation supporting:
- Design history files (DHF) / technical files
- Software lifecycle documentation (per IEC 62304 where applicable)
- Risk management files
- Verification and validation reports
- Regulatory submissions
- Serve as subject matter expert for software quality, cybersecurity, and lifecycle management, providing guidance across teams and influencing enterprise‑wide standards.
- Collaborate closely with Quality, Regulatory Affairs, R&D (software and systems), Product Management, Cybersecurity, Clinical, and Manufacturing teams to ensure software products are safe, effective, secure, and compliant.
Qualifications
- Bachelor of Science or Bachelor of Engineering in Software Engineering, Computer Science, Electrical, Biomedical, or related discipline required; Master’s degree or PhD preferred.
- 10+ years of progressive experience in software quality engineering, including regulated medical device software and/or digital health platforms.
- Strong expertise in ISO 13485 Quality Management Systems, EU MDR (Regulation (EU) 2017/745) and software implications, software lifecycle standards (e.g., IEC 62304, IEC 82304), and FDA software and quality system expectations.
- Proven ability to integrate Agile development practices with regulatory compliance, including traceability, documentation, and change management.
- Broad understanding of:
- Software architecture and system integration
- Cloud‑based systems, cybersecurity, and data privacy considerations
- Software risk management, including hazard analysis and vulnerability management.
- Strong technical leadership with advanced problem‑solving, analytical, and decision‑making skills.
