Quality Assurance Engineer
vor 4 Wochen
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 diverse teams are made up of passionate individuals who are eager to grow both personally and professionally. We are looking for team players, forward thinkers, and game changers to help us make an impact and save more lives.
If you are seeking a fulfilling career, you have found the right opportunity.
We are currently offering two positions in the Quality Assurance/Regulatory department located in Rastatt for the role of
Quality Systems Engineer (m/w/d)
Key Responsibilities:
- Maintain and enhance the Quality Management System, including the creation and review of procedures and work instructions along with associated forms.
- Provide guidance and coaching to process owners in the development 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 successfully completed engineering degree in medical technology, plastics engineering, 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 (both written and spoken) complete your profile.
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 such as JobRad and corporate 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 employ nearly 10,000 people worldwide and distribute our products in over 135 countries.
We look forward to your interest in this opportunity.
For any questions, we are here to assist you.
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