Manufacturing Quality Engineer

The Manufacturing Quality Engineer will be responsible for completing manufacturing Quality activities relating to raw materials, intermediate and final products in accordance with operational objectives, statutory and regulatory requirements and the principles of current Good Manufacturing Practice (cGMP). 

The job holder will have knowledge of our processes, products and equipment and their application as well as applicable Quality Management System standards and regulations. This knowledge will see them contribute directly towards any internal and external audits. 

The role has a strong customer focus with the job holder required to routinely liaise with key staff from other functional areas i.e. Supply Chain, Manufacturing and Research and Development to achieve required operational output and as needed escalate conflicting priorities which may arise due to planned and unplanned events to Line Manager. This will see, as far as possible, delivery against business operating schedules maintained. 

• Works within established procedure:
  • Quality Assurance release of incoming goods, intermediate and final product.
  • Ensure the accurate recording and satisfactory completion (procedure and regulatory compliance) of all relevant documentation relating to the operation and work completed.
  • Assist with the maintenance of documentation and computerised systems including but not limited to records of incoming deliveries, batch manufacturing and test records, specifications, standard operating procedures and policies, supplier monitoring files, enterprise resource planning (ERP) and quality management system (QMS) records.

• • Provide monthly metrics for, Non-conforming material, Incoming inspection results

• Preparation and management of:
  • Qualification activities of new and existing equipment/systems

• Has Working Knowledge of Quality Management System Concepts and Procedures; performs a variety of routine tasks or assignments.
  • Non-Conformance assessment
  • Change Control assessment
  • Risk assessment
  • Quality Meeting facilitation

• Continues to build knowledge of the business, processes and customers (internal and external)
  • Assist during internal/external audits from customers and regulatory bodies
  • Compile and contribute to quality metrics and trending accordingly to her activities
  • Identify areas for improvement and contribute to a culture of continuous improvement
  • Demonstrate and exhibit all key behaviours as defined by the business
  • Participate in an 'in-house' programme of continuous training and assessment

• Identifies the problem and all relevant issues in straightforward situations, assesses using standard procedures and makes sound decisions.
  • Ensure that incidents and deviations and other quality system requirements are captured, reported and fully investigated and root cause established.
  • Organise own routine work to maximise the use of available time.

• Conduct all duties in compliance with all applicable GMP, regulatory and Health and Safety requirements demonstrating a duty of care for themselves and others.

• Perform any other duties as reasonably requested from the company from time to time within the quality department .