Quality Assurance Manager

Overview

Our client is looking for an experienced Quality Assurance Manager to join their organisation. The main function of the role is to optimise processes and ensure quality. Fluency in English and German is required.

Responsibilities

• Ensuring the quality requirements for the production of medical devices as well as the associated technical documentation in accordance with ISO13485, MDR, CFR Part 820, product-specific standards, national guidelines and laws for the entire product lifecycle in the area of responsibility
• Coordination and processing of change control projects and maintenance of the associated documentation as well as coordination and processing of CAPAs in the area of responsibility
• Review and approval of documents in the lifecycle process (DMR, DHR)
• Contact person for stakeholders from the areas of production, development, and quality organization
• Support and participation in authority, customer and supplier audits and processing of audit findings
• Responsible for cleanroom support, including cleanroom monitoring and cleanroom training of internal and external personnel
• Organization and evaluation of product improvement data

Requirements

• Completed technical or scientific studies (HF, Uni, FH)
• Several years of experience in a comparable role in the field of medical devices, pharmaceuticals or healthcare.
• Knowledge in relevant quality methods (statistical methods, FMEAs, Lean Six Sigma, risk-based decision-making, etc.)
• Self-initiative and service-oriented
• Fluent in German and English

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