Senior QA/RA Officer - PCR-based IVD
Our client is an exciting and highly innovative multinational company headquartered in the United Kingdom, with operations and partners in the United States, Asia, Europe and Africa. The Company’s technology innovates the molecular diagnostic workflow, enabling delivery of rapid actionable answers to complex clinical questions at a price point accessible to both high and low resource settings.
Reporting to the QMS Manager the QA/RA Officer is responsible for helping to maintain and improve the company Quality Management System by identifying potential improvements and developing, revising and implementing Quality procedures and policies. The company is certified to ISO 13485:2016, work in compliance with BS EN ISO 14971 and develop software according to IEC 62304.
The Senior QA/RA Officer will:
- 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.
- Review software development documentation for compliance.
- 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.
Key Roles & Responsibilities
- 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.
- Support the Regulatory Affairs Manager to ensure compliance with relevant national and international standards and legislation.
Essential Experience, knowledge and requirements
- 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.