Quality system engineer

Mp resourcing - Didcot
new offer (05/04/2020)

job description

Control of all compliance related process. Control all aspects of the Document Management System including the Intranet. Ownership of QMS training administration, partnering with management to ensure all staff are made aware of the role requirements.

Main Processes:

  • Control and coordination of Customer Complaints system throughout the company to resolve complaints
  • Support in the generation of the technical reports to be submitted to the notified body and MHRA etc. regarding customer complaints
  • Control and coordination of Non-conformance (NCF) system including Supplier Corrective Action Reports (SCAR) and Concession processes
  • Control and coordination of Corrective and Preventive Action (CAPA) system
  • Control and coordination of internal and external Audit system and Deviation system
  • Maintain the Document Control processes, controlling changes to all hard copy and electronic documents maintained under the Quality Management System (including change notes, procedures and work records)
  • Maintain the company intranet and perform any necessary changes as per the change note process whilst maintaining its process within a controlled environment
  • Ensure accurate training records are maintained for all QMS related documentation
  • Work with line managers to ensure new roles and new hires have appropriate training assigned within the Company Training Management System (TMS)
  • Ensure completion of training is tracked and recorded within the TMS
  • Maintain audit compliant TMS records on all employees and relevant sub-contractors
  • Ensure systems are maintained to document training completion and escalate noncompletion

Other responsibilities:

  • Support compliance activities within the Quality System including non-conformance, audit, and deviation
  • Performing GMP review of Device History Records (DHR), working with colleagues to resolve issues where required to maintain completeness and compliance
  • Review weekly sterilisation review
  • Quality verification of all outgoing sales orders
  • Data entry and analysis of the compliance logs and quality metrics for various stakeholders across the organisation
  • Highlighting potential issues to the Quality Director
  • Provide training on Quality Systems processes as required
  • Supporting the Quality Improvement Review process
  • Control of the internal compliance logs and metrics
  • Analysing data and highlighting possible trends through the Quality Improvement Review (QIR)
  • Report on Key Performance indicators (KPIs) in order to adhere to the process and prevent occurrence of any non-conformity relating to the product, process or system
  • Supporting the Management Review process
  • Assess areas of responsibility to identify process improvement projects
  • Participate in improvement projects throughout the department
  • Manage the device tracking process, which used to track implants within the United States for its Generation III devices only

Knowledge and Experience:

  • Strong understanding of ISO 13485 requirements
  • Must have experienced of one of the following sectors: Pharmaceutical, Bio- Science or Medical Device
  • Minimum of 2 years’ experience in a Quality Systems role
  • Ability to work on own initiative
  • Strong organisational skills and structured ways of working
  • Problem-solving skills
  • Strong attention to detail
  • Ability to generate technical reports
  • High standard of written English
  • Confident user of all MS Office products
  • Clear communication verbally and in writing
  • Influencing others to comply with processes and standards
  • Experience of maintaining document management systems desirable
  • Experience within the medical devices, pharmaceutical or other highly regulated industry

Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities.

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.

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Quality system engineer

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