Quality Officer

Job Ref: J30178
Sector: Science
Sub-sectors: Biotech/Life Sciences, Medical Devices
Job Type: Permanent
Date Added: 17 May 2019
  • Oxfordshire, England, UK Oxfordshire Oxfordshire UK OX20 1TU
  • Competitive
  • Andrew Shortt
  • 0121 728 8456
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Quality Officer

37.5 hours, Mon-Fri


North Oxford

Please contact Andrew to register an interest: 0121 728 8456

My client are a leading manufacturing and innovator of medical devices, and their products offer solutions to life-saving medical care. We are recruiting for a quality officer to assist with their workload and plans going forward.

Scope of role:

Responsible for the compliance activities across all supply chain activities (supplier management, projects, distribution), to meet the requirements of ISO 13485, CFR 820, CMD/CAS, Directive 43/92 EEC, Medical Device requirements. Minimise the risk in the supply chain across all supply categories

Key Responsibilities:

  • Responsible for co-ordinating Quality activities within Supply Chain to ensure that all quality/compliance issues are addressed and actions implemented to meet the required timescale.
  • Manage supplier activities by means of quality assessments and the evaluation and introduction of new suppliers by means of quality assessment and establishing quality expectations
  • Drive continuous improvement activities with suppliers to address deficiencies identified in audits and corrective and preventive actions.
  • Develop relationships and understanding of OM's requirements with identified key suppliers.
  • Drive initiatives with suppliers to deliver measurable performance improvements.
  • Develop and manage internal and supplier audit schedules to meet the regulatory requirements.
  • Implement the supplier risk management methodology and determine appropriate strategies to mitigate risks for all Quality activities.
  • Responsible for the timely implementation of Change
  • Controls/CAPA's, Non-Conformities, investigations and Suppliers Qualification.
  • Perform supplier audits as required. Perform internal audits as required. Support Customer and Regulatory Audits.
  • Produce reports and metrics as required.

Knowledge and Expertise Required:

  • Previous auditing experience ideally in med devices, but pharmaceutical/food/biotechnology/chemicals would be considered
  • Experience of supplier qualification and/or performance monitoring would be highly advantageous
  • Experience of ISO9001/ISO13485, GMP, or similar quality systems
  • Ability to confidently liaise with associates of all levels, both written and verbal.
  • Experience in manufacturing processes and quality requirements
  • Continuous Improvement, problem solving techniques, attention to detail, analytical and methodical approach.
  • Highly computer literate e.g. Excel/Word/PowerPoint

16/06/2019 11:28:30