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This is a permanent position which comes with an excellent benefits package on offer.
Reporting into the Snr. Director QA/RA Europe & Asia, the Quality Manager will be responsible for leading and managing a Quality Team in supporting site day to day operations. He / She will promote an awareness of Quality Assurance throughout the business and ensure Quality Systems are maintained and developed in line with the site Quality Plan and Global company objectives.
• Liaise with and support all functions in managing Customer requirements and Change initiatives
• Providing Manufacturing Support and leadership to QA and Engineering teams, applying practical problem solving techniques as required.
• Provide Leadership regarding Continuous Process Improvement of the QMS and Operational Processes, with a Quality and risk management perspective
• Manage all External Audits ( Customer and Regulatory agencies ) ensuring all QMS requirements per FDA Part 820 and ISO 13485 are robust and compliant.
• Maintain a culture of compliance to QMS systems throughout the organisation including:-A compliant and timely NC / CAPA system, Change Control system, Auditing system, Validation system, Supplier Management, Records Management, DHR and DMR systems
• Ensure appropriate Risk Management systems are applied with regard to NC and Change Management.
• Ensure best practice Processes and Equipment Validation is conducted at all times.
Skills, Abilities and Education
• A bachelor’s degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required.
• The ideal candidate will have worked and thrived in the current medical device industry with the majority of their experience gained during the last 5 years. The ability to complete the tasks above on his/her own initiative is paramount. Superior communication skills are essential to deal with a growing and diverse workforce and customer base.
• Experience in managing a team of resources.
• Experience Leading External Audits by Regulatory Bodies
• Experience in leading FDA audit preparation and management
• Have thorough working knowledge and comprehensive understanding of ISO13485:2003 and 21 CFR Part 820
• Possess the drive and ability to drive systems and compliance throughout the organisation
If you are interested in making the move into a managerial role or an experienced Quality manager looking for a new challenge, then please apply directly to this advert for immediate consideration.
To find out more about Real please visit (url removed)
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
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