An exciting opportunity for a QA Specialist who is looking to move away from the corporate environment and make the next step in their career to join a growing medical devices company.
Job Title: QA & RA Specialist
Vacancy type: Permanent
Area: North West - Manchester
Salary: £35,000-£45,000 depending on experience.
SRG are working exclusively with an expanding medical device company. As a result of their continued success they have a newly created role for a QA Specialist. Reporting to the Technical Director, this is a hands on role and would suit someone looking for autonomy whilst assuming responsibility for tasks.
Working closely with the management team, you will have the opportunity to make your own mark in the company. As the company goes through its projected growth, your role and responsibilities will grow to reflect the changes in the company.
25 days of annual leave + Bank Holidays, Life Insurance & Pension Contribution
Working hours: 8.30am to 5.30pm Mon - Thurs and 8.30am to 12.50pm on Fri
- Maintenance and improvement of the ISO 13485 Quality System.
- Understand and implement current and emerging regulations (e.g. MDD 93/42/EEC, IVD 98/79/EC, proposed MDR).
- Host notified body audits.
- Compiling and updating regulatory files (Technical Files).
- Identify and drive improvement to the QMS.
- Engage all internal functions in the operation and improvement of the QMS.
- Liaising with external regulators (e.g. MHRA, notified bodies).
The ideal candidate should be educated to degree level or equivalent and should have a demonstrable equivalent experience as follows:
- Have worked at a similar level in an ISO13485 Medical Device or Pharma GMP environment.
- Developed and implemented ISO13485 / Pharma GMP procedures.
- Experience of process validation, root cause analysis, NCRs, internal and external audits.
- Previous experience of Technical Files (Medical Device or Pharma Regulatory) will be an advantage.
It's crucial that the successful individual takes full ownership of the role and as such we would expect the person to have previously managed the QA process. If you are looking for the next step in your career and would enjoy the challenge of working in a small but growing company, we would like to hear from you.
SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to Jude Madathilethu at . For more information regarding this position or any others, please call Jude on 0161 868 2212.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
Keywords: Medical Devices, ISO13485, Pharma, Pharma GMP, GMP, Quality Assurance, Regulatory Affairs, QA & RA, IVD, MDD, Technical Files, cGMP, CAPA, Deviations, RCA, NCR, Validation
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.