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vor 3 Monaten
Quality Assurance and Risk Specialist (m/w/d)
WEINMANN Emergency Medical Technology GmbH + Co. KG is a family-owned enterprise with over a century of experience in the medical technology sector, employing approximately 350 individuals. Our teams are dedicated to the development and production of innovative medical devices aimed at emergency medicine, significantly contributing to the preservation of human life.
Position Overview- Full-time role
Our department in Hamburg, consisting of 16 dedicated professionals, is responsible for the regulatory approval of our life-saving emergency devices, quality management, and product excellence. To address the increasing demands in product risk management, we are seeking an experienced risk management professional to join our team, bringing valuable insights and expertise.
Your Responsibilities:- Coordinate all risk management activities for medical devices in accordance with EN ISO 14971, covering both new developments and market surveillance.
- Contribute to and approve development plans, including the assessment and approval of verification and validation plans and reports.
- Lead product-specific "Product Quality Boards" to evaluate quality metrics as part of market observation.
- A completed (technical) university degree, preferably in engineering, along with relevant further training in risk management. Experience in quality management is a plus.
- Proven experience with technologies in the medical technology field.
- Fluent in both German and English.
- Holiday and Christmas bonuses along with additional contractual benefits.
- We prioritize work-life balance: 30 days of vacation, flexible working hours, and extensive options for remote work.
- Additional perks include subsidies for public transport, company pension schemes, and support for sick pay after the statutory entitlement period.
- Health initiatives: Access to Egym Wellpass for various sports and wellness activities, and myFürstenberg for personal development and mental health support.
- A comprehensive six-month onboarding program with insights into various departments and mentorship support.
We Simplify Saving Lives. Are you ready to contribute to the vital mission of saving lives? We look forward to welcoming you to our team.
