Exciting Medical Devices Development company seeks a highly self-motivated and enthusiastic Senior QA/RA Officer. Reporting to the QMS Manager the Senior QA/RA Officer is responsible for helping to maintain and improve the Quality Management System by identifying potential improvements and developing, revising and implementing Quality procedures and policies. The company are certified to ISO 13485:2016, work in compliance with BS EN ISO 14971 and develop software according to IEC 62304.
About the role:
- Compile and maintain Medical Device Files, Technical Files and Device Master Records in preparation for Regulatory submissions in various markets globally with guidance from the Regulatory Manager.
- Take an active role in the product risk management process.
- Take an active role in software development compliance review and approval.
- Support design review and control of change processes during product development.
- Maintain an up-to-date awareness of relevant regulations which may impact the QMS and communicate this effectively.
- Help to implement systems that facilitate productivity, improve processes and guarantee efficacy.
- Be involved in and lead training sessions to ensure the understanding and compliance of all employees.
- Administer, prepare, conduct and report internal quality system audits and external vendor assurance audits as necessary.
- Work within the QA/RA team to maintain the company's electronic Quality Management System, Q-Pulse, including monitoring and progression of CAPA and audit actions.
- Promote the benefits of the quality system to all employees.
- Plan, conduct and report validation of QMS-related software packages.
Performing a combination, but not necessarily all, of the following duties:
- Work within the Quality team to maintain focused, effective progression in line with Company Quality objectives.
- Support other members of the Quality team by providing training and mentoring on areas of expertise.
- Effectively interact with Technical, Development and Planning teams to ensure research and development is performed in accordance with company procedures.
- Work with the software development team to ensure compliance with ISO 62304 is evident and maintained in accordance with company procedures.
- Support the Regulatory Affairs Manager to ensure compliance with relevant national and international standards and legislation.
- Ensure policies and procedures are properly understood, carried out and evaluated and that modifications are investigated if necessary.
- Help to train staff in Quality and Regulatory requirements.
- Facilitate the continued work toward established goals, objectives, policies, procedures and systems pertaining to the QMS.
- Investigate relevant standards and establish clearly defined Quality methods for staff to apply.
- Define Quality procedures in conjunction with operating staff.
- Maintain process controls and documentation procedures and identify areas for improvement and efficiency.
- Support product design review and change control systems.
- Participate in the Company audit schedules for both internal and external Quality audits.
- Monitor Quality indicators and helping to gather and track relevant data.
- Identify relevant Quality-related training needs and delivering training.
- QA/QC review of contractor documentation relating to validation and verification activities as well as device manufacture records when required.
- Perform other duties that may be required from time to time.
- Degree level education in a relevant scientific or engineering-based subject.
- Experience of ISO 13485 and ISO 14971.
- Experience in working in quality assurance in the IVD sector.
- Ability to communicate effectively with all departments within the company and to represent the company in external audits.
- Experience in preparing and delivering training packages relating to Quality and Regulatory Affairs topics.
- Be eligible to work full time in the UK without restriction.
- Outstanding teamwork, a great sense of humour and ability to work in a fast-paced, cross-functional group environment, with a willingness to be hands-on across a wide range of responsibilities.
- Experience of working in compliance with IEC 62304.
- Awareness of radio equipment directive and knowledge of global radio regulations.
- Experience with ISO 60601 and its sub-standards.
- Experience in commercialisation of IVD products including knowledge of regulatory approval pathways in EU, US, and Asia.
- Experience of WHO prequalification for diagnostics.
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