Quality Engineer Validation Specialist

Medical Devices

Plymouth

Permanent Contract

Focus of the role

Reporting to the Quality Manager you will be responsible for quality compliance, technical documentation, project management and co-ordination of projects with other departments.

This job will aid in the maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC.

Role Responsibilities

• Maintain and improve quality compliance.
• Validation strategy planning, validation development, validation training and mentoring.
• Identify, manage, and implement continuous improvement initiatives.
• Evaluate product & process risks in line with Medical Device Risk Management requirements.
• New Product/Project Introductions and Validation support, protocol and report approval.
• Test Method Validation, Inspection method, testing equipment qualification (Measurement System Analysis).
• Lead Customer Complaints and CAPA.
• Support Change Control processes

Key Results Area:

• Timely resolution of identified non-conformances and implementation of effective corrective action.
• Identification of potential areas of non-conformance and timely action to prevent occurrence.
• Reduction in Quality Management System (QMS) non-conformances, and Customer Complaints & repeat process NC's.
• Timely implementation of product, process, and Quality Management System changes.
• Avoidance of product recalls.
• Compliance with approved procedures.
• Adherence to the QMS, GxP & Regulatory requirements.

Qualification & skills

• A bachelor's degree in a relevant engineering or scientific field
• Familiarity with relevant regulations and standards in the medical device industry such an ISO 13485.
• Experience in validation activities, including process validation, equipment validation, software validation, and test method validation, is crucial. Knowledge of validation protocols, reports, and regulatory requirements for validation is a must.
• Proficiency in quality management systems is important, as you will be responsible for ensuring that processes and products meet quality standards. Knowledge of document control, change control, and CAPA (Corrective and Preventive Actions) processes is beneficial.

Salary & Benefits

£40,000 per annum

You'll receive a fantastic benefits package including pension scheme, Private Medical, healthcare cover, life assurance, and much more!