Quality Systems Engineer (6 month FTC)
A global pharmaceutical family is looking for a talented and dynamic Quality Systems Engineer to join their team in Zug. This contractual role will give the excitement of a start up with the stability of a strongly grounded organisation.
- Participates in the implementation and maintenance of the quality systems program; promotes and facilitates continuous quality improvement.
- Ensures quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.
- Develops and implements measures to monitor effectiveness, metrics and Quality System process improvements.
- Develops, maintains and reports site quality metrics related to compliance, effectiveness and resolution of issues.
- Supports Quality System Lead to manage the site Corrective and preventive Action (CAPA), Non-Conformances (NC) and audits to ensure effectiveness and efficiency.
- Leads cross-functional activities related to Quality Systems on project teams such as learning
- Oversee and manages the site Quality Audit schedule and conducts internal audits as subject matter expert (SME).
- Provides support for regulatory inspections of quality systems as subject matter expert (SME).
Skills and Requirements
- Minimum Bachelor's degree in engineering, Life Sciences, or Physical Sciences
- 3+ years' experience in Quality Systems experience in medical device, pharmaceutical or other highly regulated industry
- Good working knowledge of applicable regulations and standards such as FDA QSR (21 CFR 820), MDR, MDSAP and ISO 13485.
- Fluent in German and English language.
- Experience in Microsoft Office programs ( PowerPoint, excel, Word and Outlook).
- Critical thinking skills in analysing and exercising judgement on Complex issues, guided by thorough understanding of quality philosophy.
- Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have questions, please contact Josh Volpe at 0203 800 1292 or upload your CV on our website - www.proclinical.com