Quality Assurance / Regulatory Affairs Officer
Salary Guide: £27,000 - £30,000
Harlow, Essex - Free on-site Parking
Established medical instrumentation design and manufacturer are looking to recruit a Quality Assurance / Regulatory Affairs Officer to support the Group's Companies to meet its quality / regulatory requirements.
The Quality Assurance / Regulatory Affairs Officer will provide technical support, guidance and discipline for medical device manufacturing, engineering, and distribution, in the areas of Quality Assurance, regulatory compliance, and quality systems requirements. Use of root cause analysis to address problems and identify trends. Conducts Quality Audits across all organisations.
Summary of Key Tasks:
* Support the preparation and submission of technical documentation required for regulatory market registration submissions by the QA team, including risk, post-market documentation and reports.
* Supports all the organisations to achieve root cause identification and solution resolution.
* Plan, carry out and document Quality audits.
* Maintain and co-ordinate risk assessments, Clinical review updates in line with Engineering change requests.
* Support quality awareness and improvement activities within all areas of the Company.
* Create data summaries for analysis and trend identification.
* Support purchasing with supplier investigations including LSAS compliance.
* Evaluation of Suppliers and conduct approval audits Support and liaise with internal departments regarding required corrective and preventative actions.
* Carries out evaluation of effectiveness of corrective measures.
* Conducts and supports complaints investigations.
* Liaise directly with other departments on any other matters relating to the effective running of the department and the business as a whole.
* Provide information, as requested for both internal and external auditors.
* Reporting all Vigilance incidents, which could affect quality to the Regulatory Affairs/Quality Assurance in a timely fashion.
* Supports the Quality department regarding ERP maintenance of quality modules.
* Provide support and guidance on quality and regulatory affairs to other companies within the Group.
* Ensure that LSAS objectives and targets are met.
* Ensure suppliers are set up on the system and that they complete all the relevant documentation before they are classed as approved and highlight any risks and concerns in the supply chain to the Quality Assurance and Regulatory Manager and Management Representative, including any potential country specific risks.
* To be aware of the Company's Health and Safety Policy and to ensure that any hazards and/or accidents are reported to a Health and Safety Representative as appropriate and to be aware of safety issues throughout the Company.
A comprehensive knowledge of medical device quality standards and regulatory requirements would be highly beneficial, however alternative experience in quality standards would also be considered.
You will need to have the ability to analyse and implement improvements. Good analytical IT skills are needed and experience of Microsoft Dynamics AX would be beneficial.
* Significant experience in the Medical Device industry, working to BS EN ISO 13485 Quality Management system and Medical Device Directive/Regulations - MDR 2017/745, MDD 93/42/EEC, MDSAP.
* Good understanding of GMP, LSAS & GDPR requirements.
* IT skills including knowledge of Microsoft Dynamics AX 2012.
* Knowledge of CAPA and non-conformance root cause tools.
Full job description is available upon application
Salary Guide: £27,000 - £30,000 pa
Harlow, Essex - Free on-site Parking
Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.