Your new company

Founded in Germany more than 75 years ago, our client is one of the most important players in the MedTech industry, a solution provider and partner that brings cutting technology. Precision, innovation and creativity ar the three pillars that characterize their actions towards patient safety and industry progress.

With a presence in over 70 countries, more than 9,800 employees worldwide and a range of 10,000 + medical products our client is expanding the IT Engineering Center. Looking for the best talent available on the market.

As a Software Quality Engineer (CSV / GxP) you will:

• Plan and monitor regulatory compliance strategies across the entire organization.
• Ensure that regulatory requirements under the team’s responsibility are complied with and regularly reviewed in an appropriate manner.
• Ensure compliance with regulatory reporting obligations and deadlines globally (e.g., in the context of approval activities), including information and cooperation obligations toward authorities and third parties, and fulfilling these obligations.
• Support key contacts for Software Quality Management within the organization.
• Manage software qualification and validation projects.
• Review software qualification and validation documentation.
• Review procedures and work instructions (SOPs & WIs), and implement policies and procedures for quality assurance and quality control of process software.
• Monitor and review processes based on software quality standards and best practices.
• Develop improvements in the GxP area and implementing new regulatory requirements and guidelines.

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