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Senior Quality Engineer (Medical Devices, Risk, QMS, Suppliers)

SJB Technical Ltd
Job LocationCardiff
EducationNot Mentioned
Salary£35,000 - £55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Senior Quality Engineer (Medical Devices, Risk, QMS, Suppliers)CardiffTo £55kMy client is a growing medical devices company with a innovative product that is making a significant contribution to improvements in surgical proceduresAs they further develop their products and systems, they are now seeking a medical devices Quality Engineer to provide input into all areas of the business including the QMS, projects, suppliers and risk.Experience:

  • Ideally five years’ with medical device regulations ISO 13485, ISO 14971, MDD (93/42/EEC) and MDR (2017/745)
  • Notified body / FDA inspections
  • Supplier control including auditing
  • Electronic and/or consumable medical devices development processes
  • Quality processes including CAPA, 8D, Gauge R&R
  • Statistical techniques to solve complex problems e.g. Analysis of Variance (ANOVA), Design of Experiments (DOE) etc
  • Detailed understanding of engineering drawings
    • Responsibilities:
  • QE Support to Product Development projects:
    • o Compliance overview for new product developmento Change control processes within the projectso Project quality documentationo Project technical documentation.o Project risk reduction activity (RA, DFMEA, UFMEA, PFMEA)o Design verification statistical supporto Ensuring test methods are capable and validated.o Initial Sample Inspection Report (ISIR) process
  • Supplier approval, monitoring and control processes
    • o Audits of supplier’s quality and manufacturing systems.o Supplier related issues and Supplier Corrective Action Requests (SCAR)o Supplier component qualification activitieso Work with suppliers to ensure manufacturing plan, instruction and process validation documents are produced including test methodso Initiating and progressing general improvements as identified
  • Control of non-conforming material within the company and subcontract warehouse
  • Support the Quality Manager during Notified Body audits
  • Processing company documentation changes

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