Description
Key Responsibilities:Assist in managing the Quality System compliant with FDA, ISO requirements
Liaison with 3rd partys, CMO's, Notified Bodies, Competent Authorities
Development and implementation of all aspects of Quality Systems - including CAPA, Non-conformities, Complaints handling for both paper based and online systems
Compilation of global regulatory product submissions - including CE marking and FDA
Auditing activities for company and partners
Working closely with all departments, the successful candidate will have involvement with product development and offer assistance on all quality matters associated with product transfers
Quality control systems management for all parts of manufacturing processes - incoming, in process and final specifications testing
Validation activities for products, processes and equipment
Education and Experience
Degree and/or post graduate qualification in Life Sciences or Engineering
Minimum 5 years experience of working in a regulated environment in healthcare, pharmaceutical or medical device/ IVD sector in a QA/RA role
Trained internal auditor experience
Experience of 3rd party audits by Notified Body, Health authorities, customers
Experience of FDA regulations aswell as ISO 13485 standards is preferred
Experience of writing and reviewing validation protocols
Key Skills
Fluent English essential
Advanced communication and organisational skills
Excellent PC skills in Word, Excel, Powerpoint
Good attention to detail
You will have the ability to work co-operatively and effectively with others to establish and maintain good working relationships
Proven problem solving skills
The ability to use your initiative, be proactive, work with minimal supervision
Process/procedure driven person