Quality Engineer

Willcox Matthews Ltd
Blaenau Gwent
07 Dec 2018
10 Dec 2018
Contract Type
Full Time
Quality Engineer:

We are supporting our client in their search for a Quality Engineer, who will provide expert support to the Quality Manager, managing internal NCR processes, provide quality support to the validation, supplier approval and supplier complaints processes.

Relevant Job Titles:

Quality Engineer, Quality Manager, Quality Technician, quality conformance

Position Summary:

* Provides expert support to the Quality Manager. This position is responsible for managing the internal NCR process, provides quality support to the validation, supplier approval and supplier complaints processes.

Key Responsibilities:

* Responsible for the management of the internal NCR process. Ensure that effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within the agreed timescales.

* Train relevant personnel in root cause analysis as required.

* Analyse NCR data and monitor trends to highlight further areas of improvement.

* Work closely with the engineering team to ensure all validations are carried out to the required standard.

* Review all validation protocols and reports to ensure suitability.

* Manage the rework process to ensure that any rework is identified and completed in a timely manner.

* Produce and maintain the Master Validation Plan for all products.

* Collaborate with the purchasing team to ensure new suppliers are reviewed and approved.

* Carry out supplier audits as required.

* Manage the supplier complaints process to ensure all supplier issues are recorded, SCAR raised and that supplier corrective actions are reviewed for their effectiveness.

* Ensure specifications, drawings, technical data sheets in place and maintained for all raw materials and components.

* Carry out internal audits as per the internal audit schedule.

* Produce monthly NCR KPI reports.

Minimum Requirements/Qualifications:

* Honours degree in a science or engineering subject. (desirable)

* Fully conversant in Microsoft Word & Excel and Minitab.

* Six Sigma Green or Black Belt certification (desirable)

* Previous experience in blow/injection moulding and extrusion would be advantageous.

* Formal qualifications in quality (desirable)

* Previous experience in a quality role in the medical device, IVD or pharmaceutical sectors would be advantageous

* Full member or Chartered member status of the Chartered Quality Institute would be advantageous.

Non-Negotiable Hiring Criteria:

* Lead QMS auditor qualification. (advantageous)

* Full understanding, via formal training and proven experience in the technical & quality requirements of process validation i.e. IQ/OQ/PQ, including sampling, statistical analysis, protocol and report production and review.

* Formal training and proven experience in the use of quality tools

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