Qa engineer software tester állások, munkák Németországban

• Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers
• Prepare audit findings & reports and discuss potential impact on business

• Analyze existing business processes related to GxP document management in the EUCAN region.
• Collaborate closely with the System Owner and QA Systems representatives to develop a comprehensive migration strategy into the eDMS.

The position as QC Bioassay Manager is responsible for leading a team of seven employees within the Quality Control department of AGC Biologics Heidelberg. This role entails the management and oversight of analytical testing of Bioassay Methods for Proteins and Nucleic Acids, including PCR, ELISA,...

In the position as _Global Head of Quality_ you will lead a global Quality organization and define productcentric quality strategies for established products, ensuring integration, lifecycle management, and reliable supply. You drive consistent execution and continuous improvement by embedding...

• Technical and managerial leadership of a multidisciplinary quality team
• Development and implementation of the quality strategy in alignment with overall company objectives
• Promotion of a quality culture and preventive mindset across all departments

• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

Support in the oversight and further development of the Service Provision Management System (Quality Framework)...

Ensure that the production plan is executed on time and in line with quality requirements, and set priorities according to the situation and business needs....

• Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
• Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks

• Ensure, develop and continuously improve the Quality Management System in compliance with ISO 9001, ISO 15378 and ideally ISO 13485
• Define, implement and monitor quality objectives and KPIs to drive sustainable improvement of products and processes

In the role as _Global Head of Quality Systems_, you ensure a robust and compliant Quality Management System that is fully process-based and supported by integrated IT system solutions across all GxP areas (GMP, GVP, GCP). You lead CP quality interfaces, system architecture, and data integrity...

Quality with Impact: You ensure consistent quality control and assurance at the sites, continuously updating production standards and playing key role in central quality audits....

Team Leadership & Development: Lead, mentor, and develop a high-performing team of MSAT specialists. Drive the efficiency, structure, and continuous improvement of the group's operations....

• Act as a key member of the NCE management team, providing expert guidance on all HSEQ-related matters across the region
• Lead and develop the regional HSEQ team, strengthening capabilities and ensuring effective support to operational activities

• Identify and analyze customer-specific requirements, and recommend process improvement strategies across all projects.
• Develop and standardize QA program for projects according internal and customer requirements.

• Development and continuous improvement of environmental and quality management systems.
• Ensuring compliance with occupational safety, health, environmental, and quality standards (ISO 45001, ISO 14001, ISO 9001, IATF 16949).
• Identification, assessment, and mitigation of non‑compliance risks.