Accessibility Links

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.

Similar jobs
Quality Manager
  • Job type: Permanent
  • Location: Ireland
  • Salary: Competitive
  • Description Quality Manager: A dynamic Pharmaceutical company is seeking an experienced Quality Manager for their site in Ireland. The manager will have a multitude of direct...
Director of Quality
  • Job type: Permanent
  • Location: Ireland
  • Salary: €120000 - €130000 per annum
  • Description Quality Director: A well-established multi-national Pharmaceutical company is seeking a Quality Director for their developing site in Ireland. The Director will answer to the
Associate Director Access Manager
  • Job type: Permanent
  • Location: Zürich
  • Salary: Competitive
  • Description Associate Director Access Manager Location: Zurich  With multiple products launches coming up this rapidly expanding pharmaceutical company are looking to strengthen
Associate Director Marketing (Pharmaceuticals)
  • Job type: Permanent
  • Location: Chicago
  • Salary: $120000 - $180000 per annum
  • Description One of the world’s fastest-growing pharmaceuticals firms is looking to hire an Associate Director of Marketing for their Rheumatology portfolio. This is a growth hire...
Senior Test Engineer (IEC 60601)
  • Job type: Permanent
  • Location: Gothenburg
  • Salary: Competitive
  • Description Senior Test Engineer (IEC 60601) - Medical Device Company - Sweden - Gothenburg My client is looking for Senior Test Engineer based near Gothenburg -