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Quality Assurance Manager Operations
View: 142
Update day: 26-03-2024
Category: Quality Assurance / Quality Control
Industry: Information Technology Services Computer Software Staffing Recruiting
Position: Mid-Senior level
Job type: Full-time
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Job content
Responsibilities:
- Support and enable our business partners regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility.
- Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
- Quality responsibility for
- Documents: Support business partners, review and approve documents, templates and records to ensure product quality and compliance
- Change management: Support business partners, review and approve changes to ensure product quality and compliance
- Deviation management: Support business partners, review and approve deviations to ensure product quality and compliance
- Process Risks: Support business partners, review and approve pFMEA to ensure product quality and compliance
- Support special projects or initiatives in the area of Quality and business partners
- Permanently optimize processes in order to increase quality and efficiency standards
- Technical or scientific degree or completed education in a technical profession.
- At Least 3 years professional experience with the medical device regulations including ISO 13485 and FDA regulations for the above mentioned processes
- At least 3 years professional experience with working in process improvement projects
- Solid experience with quality management
- Solid experience in a demanding interface role in a complex environment, good stakeholder management skills across all hierarchy levels to ensure a successful communication
- Very good German language skills (B2 or higher) and good English verbal and written language skills
- experience of bringing MES to production is a plus
- Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.
- solution oriented mindset
- self-dependent, structured, quality oriented and determined
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Deadline: 10-05-2024
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