Quality Systems Engineer

Job Purpose:

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.

QUALIFICATIONS 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.
• Qualified to perform Internal Audits to ISO 13485 and ISO 14001.
• Experience in maintaining a Management System certified to ISO 13485 and ISO 14001.
• Previous experience in managing a document control system.
• A complete understanding of the Medical Devices Directive 93/42/EEC
• Experience in performing Health & Safety risk assessments
• A minimum of IOSH Certificate or equivalent Health & Safety training.
• Experience in Project Delivery
• Extensive experience in compiling procedures and work instructions
• Previous experience in a similar role

KEY RESPONSIBILITIES

The Quality System Engineer will be responsible for the following:

• 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.
• Investigating EH&S concerns including accidents, incidents and near-misses to determine the root causes and establish effective corrective actions.
• Establishing, implementing and maintaining effective communication channels for the awareness and improvement of the business management system.
• 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.
• Supporting cross functional projects and continual improvements
• Any other duties assigned by the QARA Director