Quality Assurance Officer Permanent/Full Time West Midlands Competitive salary and package Do you have Quality Assurance experience?Have you worked within a Pharmaceutical/Medical Device regulated industry?Do...
QA Officer - OxfordCompetitive salary dependant on experiencePermanent full time positionAre you a degree educated scientist who has had exposure to working in a QA environment and quality management systems? Are you looking to further develop your knowledge of the QA process and help steer the company towards regulatory compliance under ISO13485. If you have a scientific and QA background this could be an excellent career move, joining a genuinely exciting medical diagnostics company during a period of growth and success.The successful candidate;
- You will be degree educated in Life Sciences with a good understanding of molecular biology
- You will ideally understand the fundamentals of molecular biology in particular qPCR
- You will have worked within a QA environment and have an understanding of IVD regulations specifically ISO13485
- You will ideally have experience training other individuals and liaising with external regulatory authorities.
- You will have a desire to contribute to the success of the company and be proactive
- Based at their facility in Oxford you will take a leading role in the Quality Assurance of novel IVD's
- Provide a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.
- You will aid in developing the QMS and ensuring the company is fully compliant with the new ISO13485 regulations
- You will liaise internally to ensure that NPD is compliant with the required regulations
- You will be involved in the auditing process as required for regulatory compliance
- You will keep up-to-date with changes in regulatory legislation and guidelines
- You will train other members of staff in relevant topics
- You will be analysing complicated information, including trial data
- Post-doctoral research, practical research or laboratory work experience
- Experience in CE marking (including the preparation of technical files and conduct of performance evaluation studies)
- Familiarity with the design and management of stability studies
- Familiarity with the management of in-house or contracted out manufacturing in an ISO9001 or ISO13485 environment
- Experience in the commissioning of packagingThis is an exciting opportunity to develop your QA career within an exciting and successful small IVD company. For more information and to discuss this role informally please call Dr. Oliver Sampson on 0121 2225332 or email
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.