QA/RA Manager

Job Ref: J23718
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 23 November 2017
  • Essex, England, UK
  • £60,000 - £80,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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QA/RA Manager - Medical Devices - Essex - £60,000 - £80,000 per annum + Benefits SRG are currently recruiting for a QA/RA Manager to join an SME Medical Device company in the Essex area on a permanent basis at a salary between £60,000 - £70,000 per annum + Benefits. Reporting to the Managing Director, you will be responsible for;* Aligning the company's business needs to regulatory, legislative change.* Managing and leading QA&RA staff in maintaining the quality management system in accordance with the company strategy, policy and regulatory requirements.* To be accountable for ensuring product and regulatory compliance is achieved in all products and supporting documentation.Key Tasks Act as the company quality management representative. Review and maintain the company quality management system ensuring quality documentation accurately reflects company activities, processes and procedures and compliance to regulatory requirements. Ensure that all staff, including Office staff, Directors, Business Development Representatives, Distributors Suppliers and Sub-Contractors are fully aware of their regulatory responsibilities and ensure adherence to them on a continual basis Review and assessment of the company Technical files and design dossiers Manage international product submission and continual registration  Determine reportable events / incidents and advice the managing director accordingly. Manage any adverse incidents and communicate all relevant parties as necessary to bring incident to satisfactory conclusion  Manage audit schedule, conduct audits or write audit reports and close out CAPA actions where applicable. Manage potential and existing suppliers/sub-contractors through performance monitoring system and QA audits to ensure desired quality and regulatory requirements are met Define regulatory pathway for the new product, new international territories. Manage CAPA system, ensuring system is fully compliant to regulations and fully utilised to ensure product non-conformance is reduced and quality system is improved Proactively search out continual quality improvement for the company quality management system  Lead QA and RA team on a daily basis. Knowledge, Skills and Experience Essential Must have knowledge and proven track record / credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485. Medical device QA & RA experience. Must be experienced manager and leader, able to demonstrate excellent communication and interpersonal skills. Must be highly motivated and maintain professional integrity. Must have experience of manufacturing. Must have experience of dealing with process validation, sterilisation, reprocessing surgical instruments. Must have energy, enthusiasm, drive and a "can do" attitude. Must have an aptitude for completing the required tasks to an excellent standard of work. Must be extremely organised in order to prioritise multiple tasks and execute them within the time. Must be able to work on own initiative as well as work within a team. Capable of handling a diverse range of projects simultaneously. Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports For more information, please call Laith Mustafa on 0161 868 2231 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.