Administrator - Quality Team
2 days ago
SPD Swiss Precision Diagnostics GmbH (SPD) is a **world leader** in the research, design and supply of advanced consumer diagnostic products and we believe we were the **first in the world to receive IVDR certificates**, for Quality Management System and Class B self-test devices. SPD was formed in 2007 as a joint venture between **Procter & Gamble (P&G)** and **Alere (now Abbott)** and our brands, such as **Clearblue**, are recognised the world over as providing accurate home pregnancy and fertility monitoring tests.
We are currently searching for a **Quality Administrator** to join our Quality team based at our **Innovation Centre **in** Bedford, UK**. This role will be a **Fixed Term Contract for 9 months**.
**Main responsibilities will include**:
- Supports development and implementation of a new archive process
- Management of archive consolidation activity
- Scanning all off site and onsite archive documentation
- Local drive consolidation activity
- Product specific tasks related to transfer of data from the cloud
- Performs other appropriate unspecific duties as directed by the Quality Systems Manager.
**We are looking for someone who has**:
Essential
- Passion for quality
- A self-starter who is self-motivated and able to plan and manage own workload
- Excellent communication skills
- An ability to build strong working relationships
- Proficient knowledge of Microsoft Word & Excel
Desirable
- Working within a regulated industry
- Ideally would have some knowledge &/or experience in the following: -- Working within ISO 13485:2016 and US FDA 21 CFR 820 environment
- EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC
- Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746
**We can offer you**:
- 25 days paid annual leave plus bank holidays.
- Bonus scheme available to all employees.
- Company pension scheme including employer’s contribution.
- Private Medical Insurance package with additional medical cash plan scheme.
- Enhanced maternity and paternity pay.
- Company supported employee Health & Wellbeing programme.
- Life assurance.
- Free parking including free electrical car charging points & disabled parking facilities.
- Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail).
**We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.
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