Quality Systems Engineer

Job Title: Quality Systems Engineer

DEPARTMENT: Quality

REPORTING TO: Quality Manager

JOB PURPOSE: Develop, establish and maintain quality systems and practices which meet the company, customer and regulatory requirements

Responsibilities:

• CAPA Coordination: Lead and manage the CAPA process, ensuring timely investigation, root cause analysis, implementation, and verification of effectiveness.
• Change Management SME: Act as a subject matter expert for change control processes, including risk evaluation and regulatory impact assessments.
• Internal Audit Program Lead: Plan, schedule, and execute internal audits in alignment with ISO 13485 requirements, including auditor training and audit readiness activities.
• External Audit Management: Coordinate and support regulatory inspections and notified body audits, including preparation, hosting, and follow-up on findings.
• Quality Management Reviews: Prepare, analyse, and present inputs for Management Review, ensuring alignment with regulatory expectations.
• Documentation Control: Maintain and improve document control processes to ensure accuracy, consistency, and compliance of QMS documentation.
• Data Trending & Reporting: Analyse quality data (e.g., complaints, nonconformances, CAPA trends) to identify signals and drive continuous improvement actions using business analytics platforms.
• Automation & Digitalization: Drive automation initiatives within the QMS, enhancing electronic systems and improving data integrity.
• AI Integration: Support the evaluation and implementation of AI-driven solutions to enhance QMS efficiency, compliance monitoring, and predictive quality analytics.
• Regulatory Compliance: Conduct gap assessments and remediation activities to ensure alignment with FDA, MDR, and ISO standards.
• Training & Awareness: Develop and deliver QMS training programs to ensure organisation-wide understanding and compliance.
• Risk Management: Support risk management activities in line with ISO guidelines, ensuring risks are identified, assessed, mitigated, and monitored.
• Supplier Quality Support: Collaborate with supplier quality teams to ensure supplier controls and quality agreements meet regulatory expectations.
• Inspection Readiness: Maintain a state of continuous inspection readiness across all QMS processes.
• Cross-functional Collaboration: Work closely with Manufacturing, R&D, Regulatory Affairs, and other stakeholders to ensure QMS effectiveness across the organization.

Key Skills and Requirements:

• Extensive knowledge of global regulatory requirements for medical devices, including FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14001.
• Experience developing and implementing procedures across QMS elements such as purchasing controls, design controls, nonconformance management, validation, and CAPA.
• Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).
• Strong communication and collaboration skills, with the ability to influence and align cross-functional stakeholders.
• Experience with enterprise quality systems and ERP platforms (e.g., Epicor) preferred.
• Prior medical device industry experience is essential.

Education and Experience:

• Bachelor's degree in Engineering or a related technical/scientific discipline preferred.
• Minimum of 5 years of experience in Quality, Regulatory Compliance, or a related field.
• Proficiency in Microsoft Office Suite required.