Quality Assurance Specialist

vor 4 Wochen


Dreieich, Hessen, Deutschland Cytiva Vollzeit
About the Role

We are seeking a highly skilled Quality Assurance Engineer to join our team at Cytiva. As a Quality Assurance Engineer, you will play a critical role in maintaining and improving our Quality Management System, ensuring that we meet customer, regulatory, and Cytiva requirements through project execution and delivery of products.

Key Responsibilities
  • Complaints Management: Receive, analyze, document, and respond to customer complaints in a timely manner, performing trend analysis to inform operational reviews, Management Reviews, and Complaint Handling Unit meetings.
  • Nonconformity and CAPA Management: Manage non-conformance and CAPA processes, ensuring root cause analysis and effective implementation of robust action plans, with follow-up and verification to prevent recurrence.
  • Internal Auditing: Monitor QA KPIs, escalating trends and ensuring continuous improvement activities, such as PSPs and CAPAs, are raised as countermeasures.
Requirements
  • Bachelor's degree in an engineering discipline (e.g., mechanical or chemical engineering).
  • Minimum 2-3 years of experience in a Quality role, preferably in the Life Sciences industry.
  • Good knowledge of using MS Office tools, such as MS Excel, for analytics and data management.
  • Ability to communicate effectively in both German and English (written and spoken).
Preferred Qualifications
  • Knowledge and awareness of Quality Control methods and techniques in the manufacturing industry.
  • Technical knowledge of systems/devices used in the biopharma field.
  • ISO 9001 certification.

Cytiva is a global leader in life sciences, and we offer a dynamic and supportive work environment, with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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