An international European company for the production of medical devices has opened a position Quality assurance specialist. In this role you will be responsible for ensuring overall implementation of the Quality management system and compliance in Russia.

Responsibilities:

Support business model changes (go-direct initiatives, new activities assessment, local labelling, etc.);
Build knowledge of local process owners, support detailed process implementation, and use of Quality tools while establishing and documenting local processes to meet local regulations;
Manage ISO (International Organization for Standardization) certification activities for applicable standards of ISO 13485:2016, and provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance;
Prepare Quality update meetings to review and discuss with local sales office Quality Performance (Key Performance Indicators) and ensure follow up and audit readiness preparation;
Act as a first point of contact on Quality for the local sales office leadership team and employees;
Representing the local “voice of the customer” to the EMEA Quality teams;
Provide Quality support to Logistics outsourced process suppliers (requirement sharing, conducting Management Reviews and Quality Walks, managing Supplier Corrective Preventive Actions, Change Control etc.), and ensuring the Quality management of local suppliers, distributors, and original equipment manufacturers;
Increase awareness on Quality topics and embed a Quality mindset in the organization to put patients first and support local organizations on identifying improvement areas.

Requirements:

Bachelor’s degree in Engineering, Business Management, or similar;
Min 2 years of relevant work experience in a highly regulated environment (Pharmaceutical, Medical Technology);
Excellent command English languages both verbal and written;
Knowledge and experience with ISO standards (ISO 9001 and ISO 13485).

Benefits:

Flexible working environment;
Fixed salary (based on interview results);
Annual bonus;
Compensation for food;
Medical and life insurance;
Compensation for mobile communications;
VHI for the employee and family members.