Scope of the Position

Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances.

Key Responsibilities

- Implement and maintain quality system to the international standard ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOP’s and revision of existing documentation within the quality management system

- Carryout internal audits to the ISO 13485 standard.

- Partake as a key team member in customer and regulatory audits as required.

- Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed.

- Monitor vendors and issue NCMR’s where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching Mergon product.

- Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities.

- Manage investigation and closure of Validation Deviations, Non-conformances and CAPA’s, including support of the investigation processes when not the owner.

- Validation: Assist with the generation and execution, where required, of validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as required.

KPIs

Quality Assurance Personnel: To learn from and to work as part of the Quality Team.

Operations Lead / Production Manager: Liaise with production team on quality issues.

Decision Making Authority

Decisions on product Quality flagged by Production, where problems arise these will be highlighted to the Quality Manager.

Person Specifications/Desirable

Bachelor’s Degree in Science, Engineering or a related field

Minimum 3years experience working at quality engineer level in an ISO 13485 regulated environment.

Internal Auditor qualified to ISO 13485

Experience with equipment validation and statistical analysis is essential.

Strong interpersonal, problem solving and attention to detail skills.

Quality Validation Engineer

Job Description