Quality Assurance Engineer

  • Location
    Glasgow, Glasgow City
  • Salary
    £ 45000 - £ 50000 / Year
  • Category
    Science - Quality Assurance
  • Job type
  • Industry
    Engineering, Aerospace and Automotive
  • External Reference

Our client in Glasgow continues to go from strength to strength and are recruiting a Quality Assurance Engineer to join there team on a permanent basis.

As a Quality Assurance Engineer for the site and network complex projects, you will be ensuring compliance is considered through all project phases, generate Quality plans, Lead Risk Assessments and Change controls.

You will have many responsibilities in this exciting role, some will include:

* Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. EPM trained and experienced facilitator for PPI activities

* Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts

* Lead QA initiatives to maintain and improve site QMS and compliance to ISO 13485, ISO 14971, 21 CFR Part 820 and IVDR

* Quality oversight for validation plans and IQ/OQ/PQ reviews

* Support Data Integrity programme� Support site Quality Management System driving effective Complaint Handling, CAPA system, Change Control, Internal Auditing, Quality Training, and Manufacturing Area Support

* Ensure the Quality Management System requirements are established and maintained, and the performance of the QMS is reviewed with Management

* Quality Expert and advisor for supporting functions and support shop floor quality improvement activities

* Lead and facilitate escalated quality investigations utilising effective problem solving and root cause analysis tools to drive robust CAPA plans

To be considered you must have the following:

* Bachelor's degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or speciality Bio medical Engineering

* Experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products

* Excellent communication, collaboration and interpersonal skills

* Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Lean Six Sigma Black Belt or trained in Lean Sigma/Six Sigma processes

* Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP, manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.

* Compliance with quality standards ((e.g., 21 CFR Part 820, ISO 13485, 9001)

* Quality tools e.g. FMEA, Risk Analysis, RCA and Global Systems e.g. TrackWise, AGILE, E1/SAP, LIMS

If you would like to discuss this fantastic opportunity further, please send your CV in today.

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.

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To speak to a recruitment expert please contact Laura Shields