QMS Specialist

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 are working with a fast growing medical device client whom have an urgent need for a Quality Systems Specialist to join the QA & compliance team.

You will play a key role in ensuring our ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved. This role will have responsibilities including creation and quality review of QMS documentation, ownership of projects driving continuous improvement, management and participation in audits and investigations, monitoring of key QMS performance indicators. You will also develop subject matter expertise in management of the companies electronic QMS.

Main Duties

• Manage and coordinate document control and training activities via the electronic QMS (eQMS).
• Contribute to the creation and preparation of documentation; Manage the review and approval of documents, including SOPs, WIs and to ensure compliance to Good Documentation
  Practices, regulatory standards, and company operating requirements.
• Provide support to users of the eQMS, assisting with initiating change requests and uploading associated documentation.
• Support the delivery of the Internal Audits, Non-conformance and CAPA management system in the business.
• Identify and own opportunities for continuous improvement across the Quality Management System.
• Perform QMS Gap Analysis to ensure appropriate reviews and approvals have taken place.
• Supporting extension to ISO Scope to include manufacturing of medical devices.
• Supporting notified body and external audits.

Education and Experience

• Experience of working in a quality assurance role within FDA and EU regulated QMS frameworks for medical device design, development, and manufacture, specifically for SO 13485.
• 3+ years experience in a similar role