Quality Engineer

This permanent position will be responsible for ensuring requirements are met with regard to the Quality Management System and associated regulations. Essential Job Functions: Participate in the following quality system activities as required:

• Compile and maintain regulatory documentation in accordance with applicable regulations.
• Manage efforts associated with the preparation of regulatory documents or submissions.
• Interpret regulatory agencies regarding presubmission strategies potential regulatory pathways compliance test requirements or clarification and followup of submissions under review.
• New Product Introduction.
• Move to One Global QMS
• Nonconformance / complaint investigation and the implementation of robust corrective action.
• Participate in an audit readiness program to ensure readiness for all audits both announced and unannounced audits.
• Assist in the analysis of quality systems with the intention of designing promoting and implementing systems and processes for continuous improvement compliance to new markets and customer satisfaction.
• Ensure the reporting of assigned quality activities is carried out accurately and in a timely fashion in keeping with the requirements of the management information system and S.O.P in place.
• Ensure the Plant hygiene and standard of GMP is maintained.
• Ensure all reports are prepared accurately and issued in a timely fashion.
• Ensure that excellent standards of quality are maintained throughout the business processes and monitor those standards on an ongoing basis.
• Carry out projects and duties as assigned by your manager in an efficient timely and costeffective manner.
• Participation in global projects as assigned by your manager when required.
• Assist in fulfilling regulatory requirements as required:
• Compiling or updating of regulatory and/or technical documentation.
• Updating of regulatory databases or systems.
• Ensure that satisfactory standards of quality and regulatory are maintained and ensure the Quality system at all times meets ISO 13485 and any other standards which may apply.

• Manufacturing Practices( Includes gowning requirements in all production areas and hand hygiene)
• Documentation Practices
• Facility Security
• Comply with all standard operating procedures in place relevant to your work activities ensuring not to perform any tasks you have not received training in.
• Comply with the requirements of the Quality Management System and relevant standards.

• Educated to degree or equivalent level in a Quality or Scientific discipline.
• Must have experience in Quality Assurance within a medical device company or pharmaceutical field.
• Experience with regulatory affairs and CAPA an advantage.
• Knowledge of Regulatory Requirements (MDD/MDR or FDA) an advantage

• Must have a flexible approach to work and be capable of handling multiple priorities in a fastpaced environment.
• Strong attention to detail with a high degree of accuracy and excellent organisational and communication skills.
• Ability to work with and empathize with colleagues and customers from varied backgrounds and cultures.