Quality Systems Evaluator

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Job Ref: J22728
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 16 July 2017
  • England, UK
  • £25,000 - £30,000 per Annum
  • Laith Mustafa
  • 0161 868 2200

Quality Systems Evaluator - Life Science - North WestQuality Systems Evaluator role primarily manages the complaint handling process at manufacturing site level which includes the assignment of complaint quality investigations, tracking and monitoring non conformances and investigations. The role also includes a wider Quality Systems management with respect to Non-conformances and CAPA. Duties and Responsibilities:* Owns the complaints process at the manufacturing site* Maintains complaint records within complaints business system* Maintains and keeps abreast of changes within the standards* Raise Non-Conformances and organise Triage for Complaint Non-conformances, coordinate and follow up complaint NCs and CAPAs to closure* Completes the complaint root cause investigation, when necessary * Reports to Corporate Quality Management on progress of complaints investigations, non-conformances and Corrective, Preventative actions.* Evaluates complaints on an ongoing basis, highlights negative and positive trends. Understands the concepts of Correction, Corrective Actions and Preventative Actions.* Provides Complaint metrics for Manufacturing * Communicates Complaint information to Manufacturing management and shop floor* Ability to interpret requests for complaint data from all customers * Support the general activities with the Quality Department, e.g. assist in coordination, follow up and closure of NCs and CAPAs * Supports inspections by regulation bodies* Conduct internal and external audits* Manage External Archive contract* Interacts with technical and operational personnel at all sites.* Compliance with GMP requirements and uphold these standards* Compliance with EHS requirements and uphold these standards * Seek and deliver CI opportunities across the site Competencies:* Knowledge of Quality Management Systems* Proficient in spreadsheet and database reporting* Understands and adheres to complaint handling regulations* Knowledge and experience of complaint handling for Life Science industry * Knowledge and experience in Corrective and preventative actions * Knowledge and experience in nonconformance process* Competent to develop knowledge of business systems * Competent to develop knowledge of product lines * Excellent Report writing skills * Strong interpersonal skills* Strong analytical skills * Experience of database and associated reporting skills* Auditing experienceFor more information, please call Laith Mustafa on 0161 868 2231 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.