Become part of a paradigm shift in renal care
As a Regulatory Specialist you will be providing technical support to the Regulatory and Risk Manager ensuring that Quanta's CE status and Technical File is maintained. You will also aid with regulatory compliance in other markets to which devices manufactured by Quanta will be introduced as well as providing support for the FDA 510(K) process. You will also need to ensure that all potential changes to standards and the MDD are understood and communicated to the relevant personnel to ensure products are future-proofed.
To succeed at this role you will need previous experience of working within a Regulatory team. Experience with Medical Devices is preferred although not necessarily with haemodialysis specifically. Experience with the implementation of the MDD and construction of the CE Technical File are also a must for this role. To stand you in good stead you will have a relevant degree, preferably in Science or Engineering (2:1 minimum), however relevant experience will be considered.
Quality Engineer - Consumables
As Quality Engineer, you will be the primary Quality contact of the Company for any outsourced suppliers who are engaged in all aspects of the manufacture of the SC+ machine. You will also be a key Quality point of contact for Tier 2 suppliers to the supply chain of the Company.
To succeed at this role you will need experience of working in a fast-paced and evolving Quality team, ideally within a Medical Device business. Prior experience of internal and external auditing, and a good range of IT skills including eQMS is also preferred. To stand you in good stead you should also have a relevant degree, preferably in Science or Engineering (2:1 minimum), however relevant experience will be considered.