Experience:

• At least 3 years of QA/RA experience (Medical Devices)
• Knowledge MDR and ISO Standards
• Knowledge of Quality managements Systems (ISO 13485)
• Working knowledge of standards and regulations as outlined in the QMS documentation and structure
• Language: English (must), German

Your Tasks

• Quality:
  • Create, review, maintain and track of Standard Operating Procedures for compliance with GMP and GDP regulatory requirements, guidelines and industry standards
  • Train employees on SOPs, GMP, GDP and quality related matters,
  • Responsible for Supplier Quality and Audits that manufacturers comply with cGMP
  • Review, analyze, and the products and processes, raw materials, components and validations, are appropriately analyzed, documented and approved/released
  • Manages the preparation and the execution of external and internal audits.
  • Performs investigations non-conformances, customer complaints and corrective actions
  • Ensures the timely and effective follow up of all identified or assigned quality issues
  • Manages device safety testing
  • Liaison for Clinical Affairs with regards to Quality compliance information
  • Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR part 820, 21 CFR part 812, and MDR
• Regulatory:
  • Identification of worldwide Regulatory requirement and relevant standards for the company's medical devices and processes
  • Responsible of registrations, certifications and communications with regulatory authorities along with submitting master files for US / EU or other markets
  • Collaboration with local Quality Managers as well as R&D and manufacturing activities such as V&V plans
  • Collaboration with application engineers and customers to define regulatory requirements, strategies and plans, as well as technical documentation