KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Design Control Officer will be varied however the key duties and responsibilities are as follows:
1.Compilation of design control and risk management documents [design control plan, design inputs, design outputs, risk analysis etc.] required to support the device design history and risk management file.
2.Review of analytical validation protocols, data and reports to ensure that they are accurate that they align with design and risk management requirements and internal processes.
3.Review product documentation (product proposals, product scope documents etc.) and assist in company purchasing controls and where required, assist in auditing duties with the Quality Team.
4.Ensure design control and risk management procedures are compliant with IVD Device standards and regulations.
To be successful in your application to this exciting opportunity as the Design Control Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a science or engineering discipline.
2. Proven industry experience of performing design control and risk management activities in accordance with QSR 820, ISO 13485 and ISO14971.
3. A working knowledge and practical experience with performing design history and risk management for IVDMIA
Key Words: Pharmaceuticals | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate | Aseptic | Biologics | Quality | IVD | In Vitro Devices
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
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