GXpeople are looking for a QARA Associate to join a Medical Device company in Surrey. Our client is an Employee Owned company where every team member has a say in how the company is run.
This is a full-time hybrid position, working 3 days in the office and 2 from home.
WHAT WILL YOU BE DOING? Contributing to the Quality and Regulatory Affairs department. Maintaining Quality Management System certification to ISO13485. Setting up and executing internal audits as directed by Quality Management and supporting on-site audits conducted by external providers. Evaluating audit findings and implementing appropriate corrective actions. Maintaining CE Marking certification, including maintaining product EU MDR technical files and managing audits from our Notified Body. Obtaining and maintaining international production registration including USA FDA, Canada, Australia, and Brazil. Keeping up to date with changing regulations. Participating in Product Development evaluation and planning, maintaining product modification records. Working closely with suppliers to ensure ongoing compliance. Training internal staff on our QA procedures; familiarity with Quality Assurance management software will be a distinct advantage.
Personal Requirements Education and Experience Ideally, 2 plus years of experience in quality and/or regulatory affairs, preferably in the medical device industry. A technical degree is preferable; some physiological grounding (such as Biomedical Sciences) would be desirable. Bachelor's degree in a technical subject preferred: biology and life sciences, electronic and electrical engineering, physics, mechanical engineering, health science. Experience working on technical documents under MDR would be very desirable.
WHAT'S IN IT FOR YOU? Competitive salary + Employee Ownership Company wide commission bonus paid monthly. Benefits related to Employee Ownership - end of year share of profits. 31 days holiday inclusive of Bank Holidays. Flexible working hours. Training to help develop you both personally and professionally. On-site parking. Cycle to work Scheme. Pension Scheme.
If you are a QARA professional who is new to the industry and are looking for a company that will not only offer you ownership but also invest heavily in your development as a QARA professional, please apply to this advert or get in touch with me.
#J-18808-Ljbffr
This is a full-time hybrid position, working 3 days in the office and 2 from home.
WHAT WILL YOU BE DOING? Contributing to the Quality and Regulatory Affairs department. Maintaining Quality Management System certification to ISO13485. Setting up and executing internal audits as directed by Quality Management and supporting on-site audits conducted by external providers. Evaluating audit findings and implementing appropriate corrective actions. Maintaining CE Marking certification, including maintaining product EU MDR technical files and managing audits from our Notified Body. Obtaining and maintaining international production registration including USA FDA, Canada, Australia, and Brazil. Keeping up to date with changing regulations. Participating in Product Development evaluation and planning, maintaining product modification records. Working closely with suppliers to ensure ongoing compliance. Training internal staff on our QA procedures; familiarity with Quality Assurance management software will be a distinct advantage.
Personal Requirements Education and Experience Ideally, 2 plus years of experience in quality and/or regulatory affairs, preferably in the medical device industry. A technical degree is preferable; some physiological grounding (such as Biomedical Sciences) would be desirable. Bachelor's degree in a technical subject preferred: biology and life sciences, electronic and electrical engineering, physics, mechanical engineering, health science. Experience working on technical documents under MDR would be very desirable.
WHAT'S IN IT FOR YOU? Competitive salary + Employee Ownership Company wide commission bonus paid monthly. Benefits related to Employee Ownership - end of year share of profits. 31 days holiday inclusive of Bank Holidays. Flexible working hours. Training to help develop you both personally and professionally. On-site parking. Cycle to work Scheme. Pension Scheme.
If you are a QARA professional who is new to the industry and are looking for a company that will not only offer you ownership but also invest heavily in your development as a QARA professional, please apply to this advert or get in touch with me.
#J-18808-Ljbffr
