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Quality Team Lead

  • Job type: Permanent
  • Location: Cologne
  • Salary: Competitive
  • Job reference: NYWH 06.12.17-2
  • Sector: EPM Scientific, Quality
  • Date posted: 06/12/2017

Quality Team Leader

A leading Medical Device manufacturing company is seeking an experienced Senior Quality Engineer required near Cologne. The Quality Team Leader will be responsible for the Quality Systems practice for Medical Devices, communicating across business areas building strong working relationships to collaborate with colleagues and customers.

Company Overview

The company is a respected member of the Medical Device world, specialising in delivering innovative solutions that integrate real time GMP manufacturing, Warehousing and Distribution of their Medical Device portfolio. The company prides itself on the quality of our services and our engaged culture, passionate about helping customers get new medicines to market.

Responsibilities:
  • Responsible for the communication and documentation of internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities.
  • Documents audit non-conformances, evaluates impact, and makes recommendations for corrective actions.
  • Communicates non-conformances to owners, managers, directors, and upper management.
  • Maintenance of the Product Specification File for individual studies.
  • Develop and ensure the validation of test methods.
  • Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Guidance of Quality, Quality Systems, and Medical Device staff in GMP requirements and issues.
Requirements:
  • Established Quality Engineering background – Quality Management Experience a plus.
  • Completed engineering degree, ideally in the field of biomedical or mechanical.
  • All applicants must be eligible to work in the EU.
  • Familiarity with FDA & EU Regulators with good knowledge of the upcoming MDR changes.
  • Fluent English necessary.
  • Sound professional experience in the field of quality assurance and a strong knowledge of Quality in GMP/GDP regulated environments
  • Established Quality Systems background – with a preference for a candidate who is a Certified Lead Auditor.
Package:
  • Ongoing training and career development.
  • Private healthcare and life assurance.
  • 30 days holiday (inclusive of bank holidays).
  • Group pension plan.
  • Employee of the quarter, food treats and staff parties.
  • Subsidised restaurant and have free parking at our site.
Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: apply.a33ho1gkg33@epmscientific.aptrack.co.uk or phone +442037588855.

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