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Quality Assurance Manager

Quality Assurance Manager

Job Title: Quality Assurance Manager
Contract Type: Permanent
Location: Konstanz, Baden-Württemberg
Industry:
Salary: €80000 - €120000 per annum
Start Date: ASAP
Reference: M0013_1611245748
Contact Name: Maximilian Köckeis
Contact Email: m.koeckeis@sciproglobal.de
Job Published: January 21, 2021 16:15

Job Description

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