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 pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• New Product Introduction.
• Move to One Global QMS
• Non-conformance / 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 cost-effective 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.

Supplemental Job Functions:

Comply with the following standard operating procedures:

• 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.

Education/Experience

• 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

Key Competencies

• Must have a flexible approach to work and be capable of handling multiple priorities in a fast-paced 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.