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Quality Auditor – Contractor – 10-30 days pa
Phagenesis Limited is a Manchester based medical device company working at the cutting edge of therapeutic neuroscience. We are seeking for certified ISO 13485 auditor to plan and execute audits in our office in Manchester and on supplier manufacturing sites across UK.
The suitable applicant will have 5+ years experience in medical device/quality assurance field and a strong understanding of the regulatory requirements applicable to manufacturers’ processes and products to ensure continued compliance with Quality System Standards.
This is a contractor role for 10 days for internal audits and up to 14 days for supplier audits in next 12 months.
The ideal candidate should have the following skills and characteristics:
• Broad knowledge of engineering and technical applications
• Internal and external auditing experience ISO 13485, GMP, MDD, IVD, CMDCAS regulations to include supplier audits, FDA, and notified bodies.
• Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes.
• Demonstrated knowledge of Quality Systems Regulations, ISO requirements and guidelines, MDD,
• Basic experience or knowledge on issue resolution disciplines (e.g., problem solving/decision making, root cause analysis, etc).
• Strong organisation, and communication skills.
• Must be reliable and capable of working with minimal supervision to manage audit planning and execution, and follow-up activities.
• Must be able to manage stressful situations and to handle controversial issues.
• Highly compliance oriented to firmly adhere to the principles of the regulations and standards.
• Ability to work effectively as part of a team or independently.
• Attention to detail
• Computer literacy skills.
The role requires:
• ISO 13485 audit certification
• Five or more years experience in Medical Device/Quality Assurance field.
Please submit your CV with accompanying letter to tarja.barnes@phagenesis.com
The first review of applications will take place on week commencing 21st August 2017.