Aktuelle Jobs im Zusammenhang mit Quality Assurance Engineer II - Bad Homburg vor der Höhe, Hessen - Fresenius Medical Care
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Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Title: Senior Supplier Quality EngineerAt Fresenius Medical Care, we are committed to delivering high-quality products and services that improve the lives of our patients. We are seeking a highly skilled Senior Supplier Quality Engineer to join our team.Responsibilities:Lead Lean Management Initiatives with suppliers to drive sustainable improvements and...
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Senior Supplier Quality Engineer
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Senior Supplier Quality Engineer
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Title: Senior Supplier Quality EngineerAt Fresenius Medical Care, we are committed to delivering high-quality products and services that improve the lives of our patients. We are seeking a highly skilled and experienced Senior Supplier Quality Engineer to join our team.Responsibilities:Lead the development and implementation of supplier quality...
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Senior Supplier Quality Engineer
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Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Title: Senior Supplier Quality EngineerAt Fresenius Medical Care, we are committed to delivering high-quality products and services that improve the lives of our patients. We are seeking a highly skilled Senior Supplier Quality Engineer to join our team.Responsibilities:Lead Lean Management Initiatives with suppliers to drive sustainable improvements and...
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Senior Supplier Quality Engineer
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Title: Senior Supplier Quality EngineerAt Fresenius Medical Care, we are committed to delivering high-quality products and services that improve the lives of our patients. We are seeking a highly skilled Senior Supplier Quality Engineer to join our team.Responsibilities:Lead Lean Management Initiatives with suppliers to drive sustainable improvements and...
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Senior Supplier Quality Engineer
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Title: Senior Supplier Quality EngineerAt Fresenius Medical Care, we are committed to delivering high-quality products and services that improve the lives of our patients. We are seeking a highly skilled Senior Supplier Quality Engineer to join our team.Responsibilities:Lead Lean Management Initiatives with suppliers to drive sustainable improvements and...
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Senior Supplier Quality Engineer
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Title: Senior Supplier Quality EngineerAt Fresenius Medical Care, we are committed to delivering high-quality products and services that improve the lives of our patients. We are seeking a highly skilled Senior Supplier Quality Engineer to join our team.Responsibilities:Lead Lean Management Initiatives with suppliers to drive sustainable improvements and...
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Senior Quality Assurance Manager
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Senior Associate Quality Assurance Specialist
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Senior Associate Quality Assurance Specialist
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Software Engineer
Vor 4 Tagen
Bad Wildungen, Hessen, Deutschland MEDICLIN VollzeitAbout the Role:We are seeking a talented Software Engineer to join our team. As a Software Engineer, you will be responsible for developing high-quality, scalable software solutions that meet the needs of our customers.Key Responsibilities:Design and implement software systems using a variety of programming languages and frameworks.Collaborate with...
Quality Assurance Engineer II
vor 3 Monaten
Objective of the Role:
This position is dedicated to supporting the validation of computerized systems within the Quality Management and Regulatory Systems department, ensuring adherence to regulatory standards and industry practices. Proficiency in TrackWise, IQVIA SmartSolve, and Quality Management Systems (QMS) is essential.
Key Responsibilities:
System Support:
- Address and resolve support inquiries related to TrackWise, IQVIA SmartSolve, and other QMS software.
- Offer technical support and troubleshoot issues for users.
- Monitor and maintain key performance indicators (KPIs) such as ticket response times, resolution rates, and customer satisfaction scores.
Validation of Computerized Systems:
- Develop and update validation documentation including validation assessments, plans, test protocols, and summary reports to facilitate system implementation in a regulated setting.
- Execute and review test protocols to support the implementation of computerized systems.
- Collaborate with business stakeholders and IT teams to establish and document business and system requirements.
Compliance and Quality Assurance:
- Ensure that validation documentation meets high-quality standards and complies with internal policies.
- Assist in regulatory audits and inspections as a Subject Matter Expert.
Documentation Management:
- Compile and maintain approved project documentation.
Communication:
- Report project and compliance issues to management.
- Escalate issues to supervisors when necessary.
Guidance and Training:
- Provide direction to external contractors involved in validation projects.
- Train users on validated systems and related procedures.
- Assist in creating training materials and programs.
Education & Experience:
- Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline, or equivalent professional experience.
- Familiarity with FDA electronic records and electronic signature requirements, as well as GAMP 5 software validation standards.
- 1-2 years of experience in software engineering, IT, or software quality assurance in a regulated environment; advanced degrees may substitute for experience.
- Experience with TrackWise, IQVIA SmartSolve, and other QMS platforms.
- Understanding of regulatory requirements including FDA, ISO, and GAMP5.
- Experience in producing validation documents such as plans, protocols, and reports.
- Participation in regulatory audits and inspections, preferably as a Subject Matter Expert.
- Documentation management skills ensuring compliance with internal and regulatory standards.
- Technical support experience for QMS software and collaboration with business and IT teams.
- Training experience for end-users on validated systems.
- Commitment to continuous improvement and process enhancement.
- Strong work ethic, analytical thinking, and attention to detail.
- Excellent communication and project management skills.
- Ability to work collaboratively and build positive relationships across teams.
- Understanding of cultural differences and effective navigation in international environments.
- Adaptability to changes in business strategies or priorities.
- Willingness to travel as needed to support projects.
