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Quality Assurance Engineer
vor 2 Monaten
Join a team with a purpose
At Maquet Cardiopulmonary GmbH, we are dedicated to making life-saving technologies accessible to more people. Our mission requires team players, forward thinkers, and game changers who are passionate about their work.
Are you looking for a fulfilling career? You have found it.
We are currently seeking a
Quality Systems Engineer (m/w/d)
Responsibilities:
- Maintenance and development of the Quality Management System, including the creation and review of procedures and work instructions, as well as associated forms.
- Consulting and coaching process owners in the creation of SOPs regarding QMS compliance.
- Training and instructing all employees on compliance and other quality-related topics.
- Managing quality system-related deviations (in CAPA or NC).
- Investigating root causes and defining and implementing corrective actions.
- Planning, conducting, and coordinating internal audits.
- Supporting external audits (Third Party Audits / FDA, DEKRA, etc.) and management reviews.
Your Profile:
- A successfully completed engineering degree in medical technology, plastics technology, 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 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 a pronounced sense of project management and time management.
- Excellent German and English language skills (written and spoken).
We Offer:
- High-quality products in a life-saving environment.
- Competitive compensation, 30 vacation days per year, and additional attractive conditions.
- Flexible, family-friendly working hours and the option for remote work.
- Employee benefits and discounts.
- 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 optimize workflows. 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 questions, we are happy to assist you.
