Quality Systems Engineer – 9 Month Contract

Drive quality excellence and regulatory compliance in a cutting-edge medical technology environment.

R&D Partners is seeking a Quality Systems Engineer to support the execution, maintenance, and continuous improvement of the Quality Management System (QMS) for a leading medical technology and devices company. This role ensures full compliance with applicable regulatory standards, including FDA 21 CFR Part 820, EU MDR, and ISO 13485.

Please note that to be considered for this role you must have the right to work in this location.

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, analyze, 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: Analyze quality data (e.g., complaints, nonconformances, CAPA trends) to identify signals and drive continuous improvement actions.
• 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 organization-wide understanding and compliance.
• Risk Management: Support risk management activities in line with ISO 14971, 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 14971.
• 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., SAP, EtQ) preferred.
• Prior medical device industry experience is essential.
• Experience with Software as a Medical Device (SaMD) and Class II medical devices is preferred.

Education and Experience:

• High school diploma or equivalent required.
• 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.
• CQE or equivalent certification preferred.
• Proficiency in Microsoft Office Suite required.

For more information, please contact Toby Shelton.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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