Quality Manager - Systems

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Quality Manager - Systems

Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter & Gamble (P&G) and Abbott; and our brand Clearblue, isrecognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Quality Manager - Systems to join our Quality team on a Full-Time, Permanent basis.

The role will be based at our Innovation Centre in Bedford, UK with option for Hybrid Working.

Reprting in to the Global Quality Director, the Quality Manager - Systems has overall accountability for the adequacy, effectiveness and continuous improvement of the Quality Management System.

The role is responsible for ensuring the delivery of all QMS related activities, including:

  • Document Control and Standards Monitoring
  • CAPA & Non-conformances
  • Internal and External Audits
  • Risk Management
  • Computer System Verification
  • Training

We’re looking for someone who has experience of ensuring and managing quality and compliance within a medical device environment. Applicants must have sound knowledge of ISO 13485:2016, US FDA 21 CFR 820 & ISO 14971:2019, and ideally EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC and Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746. A Lead Auditor qualification or equivalent experience is desirable.

The role holder will be expected to understand and adapt to their audience so good interpersonal skills and excellent written and oral communication skills are essential. Having the ability to communicate persuasively to gain commitment will be advantageous along with the ability to drive compliance as a competitive advantage.

We can offer you:

  • Hybrid working
  • 25 days paid annual leave plus bank holidays (pro-rata)
  • Company pension scheme including competitive 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 electrical car charging points
  • Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail)

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.

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.

The Company

SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.

Our SPD research centre is at the cutting edge of innovation, and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.

Required skills

  • Medical Devices
  • Quality Management
  • Certified Lead Auditor
  • Quality Management Systems
  • ISO13485

Reference: 52348360

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