Quality Engineer System Compliance

Quality Engineer System Compliance

Job Title: Quality Engineer System Compliance
Contract Type: Permanent
Location: Göttingen, Niedersachsen
Salary: Negotiable
Reference: ID125748_1607511168
Contact Name: Michael Burgstaller
Contact Email:
Job Published: December 09, 2020 10:52

Job Description

Please apply exclusively with a resume in English language

CV to:

What you will accomplish together with us

  • Your main responsibility is to improve, harmonize and maintain existing Quality Systems on a global scope

  • Therefor you lead gap analysis and start corrective actions as projects to fulfill all required standards

  • To realize the project you will provide effective tools and knowledges

  • Additionally you identify new best practice approaches for quality systems and provide guidance rule for processes and standard procedures

  • Also you will ensure documentation processes with respect to normative and regulatory requirements by setting up SOP´s

  • You will implement these SOP´s in the global Sartorius network and train employees when it is needed

  • The Coordination and/or Performance of internal Audits, with notified body's and for our joint audit program Rx360 within the BPS group is another responsibility for this position

  • As well you will ensure a continuous communication to external and internal stakeholders especially to our site quality units

  • Finally you start and lead inter site projects together with our local teams

What will convince us:

  • You have finished your Bachelor or Masters degree with a quality related focus

  • Additionally you have several years of profound professional experience in quality | quality system management, desirably in pharmaceutical or food industry

  • Strong knowledges of regulatory norms and conditions like ISO 9001 | ISO 13485 | GxP are necessary

  • Also you gained experience in project management for quality related projects

  • As well you have basic knowledges with SixSigma (process capabilities | MSA | SPC)

  • Strong communication and negotiation skills combined with high assertiveness round of your profile

  • We presuppose fluent English and German language skills and the willingness to travel (approx. 10%)

  • Identification with our core values: Sustainability, Openness, Enjoyment

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