e-QMS Implementation Specialist

e-QMS Implementation Specialist

A great opportunity has become available within an exciting medical devices organisation. The company is transferring paper records to an electronic QMS (eQMS) system.

As an experienced Quality Assurance (QA) professional, you ll be knowledgeable of medical device regulations, and quality system implementation. The role focuses on migrating paper documents (SOPs, records, etc.) into a compliant electronic system while ensuring data integrity and adherence to ISO 13485 standards. Key responsibilities would include document review, data conversion, validation, and training, with a core requirement to maintain regulatory compliance throughout the transition.

Working within a cross functional team, you ll project manage the implementation, including training to teams within the organisation.

Key Responsibilities:

1. Document Analysis and Migration:
2. System Configuration:

Work with the eQMS to establish appropriate document control and workflow templates, ensuring the system supports the company's quality processes.

1. Validation and Quality Control:

Implement validation procedures to confirm the correct migration and functionality of migrated documents and data within the eQMS.

1. Regulatory Compliance:

Ensure all migrated content and new processes comply with relevant regulatory standards, particularly ISO13485, for medical device quality management.

1. Training and Support:

Train personnel on how to use the eQMS for new document management processes and provide ongoing support.

1. Audit Readiness:

Prepare the eQMS for internal and external audits, demonstrating that all quality processes and records meet regulatory requirements.

Required Skills and Qualifications:

• Regulatory Knowledge: Strong understanding of ISO 13485 and other relevant medical device regulations (e.g., FDA regulations).
• Technical Proficiency: Familiarity with eQMS software platforms and data entry tools.
• Document Control Expertise: Experience in managing and controlling documents, including their review, approval, and archiving.
• Problem-Solving Skills: Ability to identify and resolve issues that arise during the data migration and eQMS implementation process.

This is an exciting role with labs based in Oxfordshire. The company has parcking on site and good public transport links.

We look forward to receiving your application.