Вакансія Quality Assurance Specialist в місті Москва
Код вакансії: 6180243128c9de00113c4d12

Quality Assurance Specialist

An international company has opened a competition for the position of Quality Assurance Specialist.

 

Responsibilities:  

  • Establish local and regional relationships with regulatory affairs, commercial, and logistics team; 
  • Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring); 
  • Implements and supports Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance; 
  • Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD; Directive/Regulations, MDR Japan JPAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA; 
  • Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics; 
  • May serve as in-country Quality representative aligned with local regulations or laws (e.g. Mexico Sanitary responsible); 
  • Participates and hosts internal and external audits;
  • May serve as liaison between local health authority and the business; 
  • Supports quality team for a comprehensive audit readiness program to ensure internal and external quality compliance; 
  • Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs; 
  • Maintains quality oversight of any local required establishment licenses, or QMS certifications; 
  • Maintains local supplier/vendor selection, qualification, and audits; 
  • Maintains process for kitting/repack/relabeling activities (if any); 
  • Maintains quality records and adherence to records retention policies and procedures; 
  • Maintains quality oversight of field service processes/procedures; 
  • Maintains quality training program with respect to quality system elements; 
  • Establish corrective and preventive actions to mitigate potential or actual noncompliance risks; 
  • Assesses product quality issues and escalates to upper management through established processes; 
  • Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management; 
  • Ensures timely and consistent escalation of events; 
  • Responsible for communicating business related issues or opportunities to next management level. 

Requirements:  

  • Higher education, scientific background is a plus (Biology, Chemistry, Medical devices, Pharma); 
  • Knowledge of ISO 13485 and 21 CFR 820; 
  • Ability to effectively negotiate and influence above; 
  • Practice in developing SOPs, processes, working instructions; 
  • English - Upper-Intermediate; 
  • 3 years of experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field. 

Conditions:  

  • Competitive salary and bonus system; 
  • Medical insurance ( for an employee and family members); 
  • Food compensation; 
  • Mobile communication; 
  • Great opportunities for professional and career growth.
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