Quality System Engineer - Maternity Cover

South Wales

Maintain the Business Management System certified to ISO 13485, ISO 14001 and MDSAP in compliance with applicable standards, legislation and directives, and ensure devices designed, manufactured and distributed are safe and effective throughout the product lifecycle.

Key Responsibilities:

  • The Quality System Engineer will be responsible for the following:

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  • - Maintaining the Integrated Business Management System certified to ISO 13485, ISO 14001 and MDSAP.

  • - Performing internal quality and environmental audits.

  • - Maintaining the Document Control System.

  • - Providing training to employees in the business management system procedures and processes when required.

  • - Establishing, implementing and maintaining effective communication channels for the awareness and improvement of the business management system.
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  • - Performing regular trending of business management system processes and compile reports for presentation to Senior Management.

  • - Compiling and reviewing Standard Operating Procedures, Work.

  • - Instructions and other relevant documentation to ensure compliance with the business management system certified to ISO 13485 and ISO 14001.

  • - Working with the Design & Development department to ensure projects are completed to approved Design Control procedures.

  • - Compilation and proof-reading of product technical documents.

  • - Verification of materials, product, equipment and processes.

  • - Maintenance of the CAPA system.

  • - Supporting cross functional projects and continual improvements.

  • - Any other duties assigned by the QARA Director.

Qualification and Experience:

  • The Quality System Engineer will have the following qualifications and experience as a minimum:

      • - A degree or equivalent in a relevant engineering, science or management system discipline, or equivalent.
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      • - Qualified to perform Internal Audits to ISO 13485 and ISO 14001.
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      • - Experience in maintaining a Management System certified to ISO 13485 and ISO 14001.
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      • - Previous experience in managing a document control system.
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      • - A complete understanding of the Medical Devices Directive 93/42/EEC.
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      • - Experience in Project Delivery.
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      • - Experience in compiling test protocols and reports.
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      • - High degree of literacy and communication skills.
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      • - Extensive experience in compiling procedures and work instructions.
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      • - Ability to understand and proof-read technical, medical device documents.
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      • - Knowledge of design control processes.
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      • - Experience in maintaining CAPA and/or 8D systems.
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      • - Previous experience in a similar role.

To apply please email fionawalters@hcexec.co.uk