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Quality Systems Engineer
vor 2 Monaten
**About GULP – experts united**
We are a leading company in the medical technology industry, offering innovative solutions for healthcare. Our focus is on quality and safety, and we develop and manufacture products used in hospitals and healthcare facilities worldwide.
**Job Summary**
We are seeking a highly skilled Quality Systems Engineer to join our team. As a Quality Systems Engineer, you will play a critical role in maintaining and developing our Quality Management System (QMS).
**Key Responsibilities**
- Develop, review, and update procedural and work instructions, as well as associated forms, to ensure compliance with quality standards.
- Advise and coach process owners in creating standard operating procedures (SOPs) and ensure QMS compliance.
- Train and instruct employees on compliance and quality-related topics to ensure a high level of quality awareness throughout the company.
- Process deviations in the quality system, including analyzing and rectifying CAPA and NC processes.
- Investigate the causes of deviations and define and implement suitable corrective measures.
- Plan, conduct, and coordinate internal audits to ensure compliance with quality standards.
- Support external audits, such as third-party audits, FDA inspections, and DEKRA audits, as well as management reviews.
**Requirements**
- Engineering degree in medical technology, plastics technology, mechanical engineering, or a comparable qualification.
- Several years of professional experience in the medical technology industry and sound knowledge of quality management.
- Familiarity with quality management standards for medical devices, such as ISO 13485, 21 CFR 820, as well as risk management in accordance with ISO 14971 and GMP for medical devices.
- Knowledge of the Medical Devices Act (MPG) and statistical knowledge are an advantage.
- Excellent presentation and moderation skills, strong project management, and time and self-management skills.
- Very good command of written and spoken German and English.
