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

Cardiff, Cardiff, United Kingdom, £ £ 35000.00-55000.00 Annual Annual, Permanent


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


To £55k

My client is a growing medical devices company with a innovative product that is making a significant contribution to improvements in surgical procedures

As 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.


  • 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


  • QE Support to Product Development projects:

o Compliance overview for new product development

o Change control processes within the projects

o Project quality documentation

o Project technical documentation.

o Project risk reduction activity (RA, DFMEA, UFMEA, PFMEA)

o Design verification statistical support

o 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 activities

o Work with suppliers to ensure manufacturing plan, instruction and process validation documents are produced including test methods

o 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

Job Details

Not Specified
Cardiff, Cardiff, United Kingdom
£ £ 35000.00-55000.00 Annual Annual