Senior Software Quality Engineer

Skillsource is supporting a global leader in the medical technology sector to hire a Senior Software Quality Engineer for a highimpact role within a rapidly developing R&D and software innovation environment.

This position supports the establishment and strengthening of quality systems software compliance processes and designassurance oversight for new product development and technology transfer initiatives. The role will suit a quality professional experienced in regulated software development design controls lifecycle management and crossfunctional collaboration.

Role Purpose

The Senior Software Quality Engineer will act as a key quality representative supporting project teams engaged in software development manufacturing transfer and operational improvement initiatives. A core part of the role involves contributing to and shaping the Quality Management System (QMS) for the site with emphasis on design control process validation supplier oversight and technology transfer practices.

You will be expected to provide leadership on software quality and regulatory compliance including computer system validation risk management documentation review and ensuring adherence to global standards throughout the product lifecycle.

Key Responsibilities

Quality Engineering Leadership

• Support the development enhancement and maintenance of quality strategies processes and plans related to software quality test coverage system performance and compliance.
• Provide both strategic and practical support to Quality Engineering activities based on regulatory expectations and industry best practices.
• Represent the Quality function on New Product Development and Technology Transfer Core Teams.

Design Control & Documentation

• Own and facilitate Design Review and Functional Review processes for softwarerelated products and subsystems.
• Review and approve softwarerelated documentation including requirements specifications design artefacts verification/validation protocols and reports.
• Evaluate software drawings documentation updates and change requests to ensure accuracy and compliance.

Regulatory & Standards Compliance

• Ensure all relevant activities comply with applicable regulations and standards including:
  • 21 CFR 820 (Quality System Regulation)
  • 21 CFR 11 (Electronic Records & Signatures)
  • ISO 13485 ISO 14971
  • IEC 62304 (Software Lifecycle)
  • Other applicable device and regulatory frameworks
• Oversee computer system validation activities and assess compliance with electronic record requirements.

Risk Management

• Lead or contribute to software risk management activities across development verification validation and transfer.
• Apply structured analytical tools (root cause analysis statistical analysis reliability principles) to identify issues and support problem resolution.

CrossFunctional Collaboration

• Work alongside R&D Manufacturing Engineering Operations and Regulatory Affairs to support software design improvements enhance reliability and drive measurable product enhancements.
• Manage and coordinate responses to findings from audits CAPAs and assessments related to software compliance.

Quality Assurance & Continuous Improvement

• Ensure that internal policies procedures and engineering practices align with relevant regulatory guidelines.
• Support remediation of softwarerelated nonconformances audit findings and CAPA activities.
• Contribute to the evolution of quality processes and culture across the site.

Candidate Profile

Essential Qualifications & Experience

• Bachelors degree in Electrical Mechanical Software Biomedical Engineering or related technical field.
• Minimum 67 years of experience including 4 years in software development software lifecycle management or softwarerelated quality roles.
• Strong understanding of design control validation statistical sampling Six Sigma tools and project management methodologies.
• Experience in applying structured problemsolving approaches including root cause analysis failure mode analysis and risk assessment.
• Excellent documentation communication and presentation skills with an ability to tailor messaging to different audiences.
• Demonstrated ability to manage multiple priorities and drive change through crossfunctional teams.
• Working knowledge of FDA ISO and other regulatory frameworks relevant to softwareenabled medical devices.

Desirable Attributes

• Experience supporting software design for complex embedded systems.
• Exposure to technology transfer environments or new product introduction projects.
• Ability to facilitate conflictresolution and maintain momentum in technical teams.

Working Model

This is primarily an onsite role requiring up to four days per week on site to support collaboration problemsolving and alignment across multidisciplinary engineering teams.

Contract Details

• Type: Fulltime
• Level: MidSenior
• Travel: Occasional
• Security Clearance: Not required
• Visa Sponsorship: Not available

Why Apply

This role offers the chance to influence the quality and regulatory direction of cuttingedge medical software products. You will shape quality processes for a growing innovation site collaborate with highcalibre technical teams and contribute to software that supports lifeenhancing medical technologies.