Quality Systems Specialist: ISO 13485 & eQMS Expert

Lenntech Search; Oxford; Hybrid; GBP 40,000 - 65,000; Full time

Benefits offered by this job

Health insurance

Job summary

LennTech Search is seeking a Quality Systems Specialist to join the QA & compliance team for a medical device client. You will establish, implement, maintain, monitor, and continuously improve the ISO 13485 QMS and oversee documentation control, audits, CAPA, and change management.

You will develop expertise in managing the electronic QMS and support ongoing expansion of the quality system to include manufacturing activities, as well as assist with external audits and regulatory compliance.

Qualifications

• Experience in FDA and EU regulated QMS for medical devices (ISO 13485).
• Minimum 3 years in a quality assurance role.
• Experience with document control, internal audits, CAPA.

Responsibilities

• Manage document control and training activities via the eQMS.
• Review and approve SOPs and work instructions to ensure regulatory compliance.
• Support users of the eQMS, initiate change requests, and upload documentation.
• Assist Internal Audits, Non-conformance and CAPA management processes.
• Identify opportunities for continuous improvement across the QMS.
• Perform QMS Gap Analysis to ensure proper reviews and approvals.
• Support expansion of ISO scope to include manufacturing of medical devices.
• Assist with notified body and external audits.

Skills

Quality assurance

QMS frameworks

ISO 13485

Regulatory compliance

Documentation control

Tools

eQMS (electronic QMS)

Job description

LennTech Search is seeking a Quality Systems Specialist to join the QA & compliance team for a medical device client. You will establish, implement, maintain, monitor, and continuously improve the ISO 13485 QMS and oversee documentation control, audits, CAPA, and change management.

You will develop expertise in managing the electronic QMS and support ongoing expansion of the quality system to include manufacturing activities, as well as assist with external audits and regulatory compliance.