We are proud to be partnering with a company that is pushing the boundaries of cutting-edge medical additive manufacturing. They are an inclusive, fats-growing, innovative business, and operation on a patient outcome focus.
They have identified the need for another professional to come and join the QARA department. As the QARA Specialist, you will contribute to the development of new products, drive improvements in the company's standards and maintain regulatory accreditations. You must have a passion and deep understanding of QMS culture in the MedTech industry. Your role will be vital to driving the company forward throughout new products and markets expansion (US and Canada).
This is a long-term opportunity smart and exceptionally talented individuals with creativity in approaching problems or tasks.
Candidates must live or relocate nearby Bath or within short commutable distance.
The ideal candidate will also have experience / knowledge in SaMD validation and familiarity with software regulations in line with new MDR and relevant standards.
- Bachelor's degree with scientific, engineering, regulatory, quality or legal core competency
- 3+ years' experience in QA/RA role in surgical devices and MedTech product quality validation
- In-depth knowledge of ISO:13485, ISO:14971, CE marking, MDR, FDA 510(k)
- Excellent PC skills, including QMS software applications.
- Organisational skills and problem-solving approach
- Strong written communication skills: plans, procedures, work instructions and reports
- Experience in Software validation IEC:62304 and SaMD process certification
- Bilingual or with good knowledge of a second language
- Apply for and maintain approval of ISO, CE, MDR standards for our devices
- Internal /external audit, CAPA process
- Preparation for IEC approval of software components
- Capable of promoting a culture of best practice
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
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