Pharma Medical Device Company based in Loughborough
Basic upto £45,000 plus performance related bonus, and up to six figure stock options, and Private Medical
•Overall responsibility for the administration and development of the Quality Management System for ISO13485 and 9001
•Management of Non-Conformance's, including root cause analysis and corrective actions
•Compliance with ISO 9001:2015 and ISO 13485:2016 certification requirements
•Working with the other department heads for the continued development and implementation of a Quality Assurance culture, including but not limited to:
•Management, further development and training of the Quality Control department to ensure suitable testing and inspection processes are applied at the relevant points of the process
•Working with the production team to implement effective solutions to quality issues
•Involvement in company-wide continuous improvement activities
•Internal and supplier audits, UK and overseas
•Risk assessments, FMEA and Hazard analysis for new product development
•Build strong cross-functional working relationships with manufacturing staff and other departments within the business to engender a Quality Culture.
•Conduct risk assessments and gap analysis of the current quality systems and formulate actions plans accordingly to continuously improve the Quality Management system.
•Support Complaint investigation and closure review to maintain compliance with regulatory expectations.
•Provide Validation support across the business, in line with regulatory requirements.
•Support the Change Management system to maintain a 'State of Control' across the business.
•Maintain an overall knowledge of the current status of compliance across site with rules and standards and maintain an awareness of developments in the field of Medical Devices & GMP to ensure a continued provision of an up to date service
•Compilation of Technical file for medical devices, for CE and US approvals
-Graduate with appropriate post-graduate and professional training
-Minimum 8 years Industry experience