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Quality Assurance Engineer
vor 2 Monaten
Join a team dedicated to making a difference
At Maquet Cardiopulmonary GmbH, we are committed to providing life-saving technologies to a broader audience. Our mission is to enhance clinical outcomes and optimize workflows in healthcare settings. We are looking for passionate individuals who are eager to contribute to our vision.
We are currently seeking a
Quality Systems Engineer (m/w/d)
Key Responsibilities:
- Maintain and enhance the Quality Management System, including the development and review of procedures and work instructions, as well as associated forms.
- Provide guidance and coaching to process owners in the creation of SOPs and ensure QMS compliance.
- Train and instruct all employees on compliance and other quality-related topics.
- Address quality system-related deviations (in CAPA or NC).
- Investigate root causes and define and implement corrective actions.
- Plan, conduct, and coordinate internal audits.
- Support external audits (Third Party Audits / FDA, DEKRA, etc.) and management reviews.
Your Profile:
- A degree in engineering, preferably in medical technology, plastics engineering, or mechanical engineering, or a comparable qualification.
- Ideally, several years of professional experience in the medical technology field.
- Solid knowledge in quality management.
- Familiarity with quality management for medical devices, including ISO 13485, Quality System Regulation 21 CFR 820, risk management for medical devices ISO 14971, GMP for medical devices, and the Medical Devices Act (MPG).
- Statistical knowledge is desirable.
- Strong presentation and moderation skills, along with excellent project management and time management abilities.
- Proficient in both German and English (spoken and written).
We Offer:
- High-quality products in a life-saving environment.
- Competitive compensation, 30 vacation days per year, and additional attractive benefits.
- Flexible, family-friendly working hours and the option for remote work.
- Employee discounts and corporate benefits.
- Career opportunities within a reputable company.
- Individual onboarding and training opportunities.
- Modern workplace equipment.
About Us
At Maquet Cardiopulmonary GmbH, we believe that everyone should have access to the best possible healthcare. We provide hospitals and life science institutions with products and solutions that improve clinical outcomes and streamline operations. Our offerings include products and solutions for intensive care, cardiovascular procedures, operating rooms, sterilization, and life sciences.
We look forward to your interest in this opportunity.
For any inquiries, please feel free to reach out.
