Job Description: Quality Engineer
Primary Role:
§ To lead in the implementation, monitoring and maintenance of quality best practice, GMP/GLP and the Quality Policy, SOP’s, standards and procedures of Sphere Medical Ltd.
§ To be pro-active in the development and maintenance of the Sphere Quality Management System.
§ To work closely with key stake-holders towards achieving and sustaining agreed and specified quality levels, performance and customer satisfaction.
§ A champion of quality and a bold driver of positive improvement.
Other Roles:
§ Working with others to maintain and uphold the documented Quality Management System.
§ Representing the quality function through the active participation at project meetings, design reviews and risk analyses.
§ Generating, reviewing and approving of quality-related support documentation.
§ Ensuring that goods-in requirements are met and where necessary working with suppliers to assure their consistent performance and delivery.
§ Facilitating corrective action and preventive actions aimed at addressing quality issues. This includes leading in appropriate investigations associated with product manufacture, supplier performance and customer feedback and complaints.
§ Helping to maintain and schedule the calibration and maintenance of test equipment, including the supplier approval and monitoring of any external calibration services.
§ Undertaking internal audits including coordinating the associated follow up of any corrective actions.
§ Assisting with supplier assessment though personal contact, visit and audit.
§ Supporting in the development and undertaking of appropriate verification activities for equipment, product and processes including related acceptance testing and validation where deemed appropriate.
§ Preparing presentations and delivering related training modules.
Skills:
§ A thorough understanding of Quality Management Systems especially the requirements of ISO 13485 and FDA 21 CFR part 820.
§ Strong people skills.
§ Competent with Microsoft Word, Excel, Powerpoint and Access.
Personal Attributes:
§ Demonstrates the ability to enthuse, influence and motivate others around them.
§ A confident and effective communicator at all levels.
§ Displays a willingness to be bold and to lead by example.
§ Able to be strong in maintaining the control of existing systems, yet flexible and receptive to change and ongoing improvement.
§ Ability to absorb lots of data and changing information and to revise priorities as appropriate.
§ A strong team player with leadership abilities.
§ Well organised and methodical.
§ Able to travel when required.
Education:
§ Degree or HND in a relevant Engineering discipline.
§ Full driving licence preferred.
§ A trained internal auditor.
§ LSS training an advantage e.g. is a certified Green Belt or above.
Experience:
§ Working within the medical device industry ideally with electronic or electrochemical technologies
§ Has a practical knowledge and experience in a range of quality techniques, methods and tools.
§ Hosting suppliers, dealing with customers and working with regulatory bodies such as Notified Bodies, MHRA and the US FDA.
FM:113 Issue 1 22 April 2009 Page 1 of 2