Quality Engineer - Medical Devices/Pharmaceutical

Job Title: Quality Engineer - Medical Devices/Pharmaceutical
Contract Type: Permanent
Location: Keighley, West Yorkshire
Salary: Negotiable
Reference: J899428_1552408798
Contact Name: Tom Hammond
Contact Email:
Job Published: March 12, 2019 16:39

Job Description


Location: Keighley

Type: FTC, occasional travel to the Southern site (expenses provided)

Duration: 12 months (could be extended or potentially lead to a permanent role)

Salary: Competitive DOE

This position reports into the Manufacturing Quality Manager

Our Client, a Global Medical Devices company are looking to appoint an experienced QE to be involved in a large product and process equipment transfer project.

The Role:

  • Liaise with Relevant Departments on the completion of risk assessment, Work Instructions, Validations and FMEA's for both new product introductions and existing product line changes/process improvements.
  • Contribute to, review and/or develop and execute facility, software, process and equipment validations and risk management documents
  • Review change controls for process/design impact.
  • Knowledge of statistics to assist with validation developments and process improvements
  • Provide quality support to relevant departments with sampling plans, data processing or analysis for validation for new and existing product lines.
  • Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
  • Complete CAPA investigation, processing and disposition.
  • Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
  • Perform Internal Audits/Supplier Audits.
  • Assist in the development, analysis and improvement of site Quality Metrics.
  • Lead/Support project activity in your area of responsibility
  • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
  • Will comply with all relevant training required and adhere to relevant associated documentation.
  • Follow strict adherence to the requirements of cGMP.
  • Liaise/support with suppliers to ensure drawings and specifications are clear, understood and fully compliant.

The Person:

  • Will hold a Degree in a relevant / Scientific discipline or a Degree in Engineering
  • Experience of working within a Quality environment within the Medical Devices / Pharma Industry in a QE related position with extended experience in change controls and validation

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