Quality Assurance and Risk Specialist

vor 4 Wochen

Hamburg, Hamburg, Deutschland WEINMANN Emergency Medical Technology GmbH + Co. KG Vollzeit


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 dedicated professionals. Our teams are engaged in 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 skilled colleagues, is responsible for the regulatory approval of our life-saving emergency devices, quality management, and product excellence. To address the increasing challenges in product risk management, we are seeking an experienced Risk Specialist who will bring valuable insights and expertise to our team.

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.
Your Qualifications:
  • 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.
What We Offer:
  • 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.
Join Us in Our Mission to Save Lives

If you are passionate about making a difference in emergency medicine, we look forward to welcoming you to our team.

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