Карьера

Если вы разделяете цели «Стентекса» — создать и развивать производство высокотехнологичных медицинских изделий в России, если хотите реализовать свои способности в международной команде и обладаете нужными нам знаниями и опытом, добро пожаловать в компанию.

Мы ищем состоявшихся и молодых специалистов: активных, творческих и неравнодушных людей, готовых развиваться, отвечать за качество на уровне самых высоких мировых стандартов и разрабатывать новые медицинские изделия, конкурентоспособные на глобальном уровне. 

Мы стремимся создать для своих сотрудников возможности для развития и карьерного роста, социальные гарантии, обеспечить безопасные условия труда и его достойную оплату. 

Если вас заинтересовали предложенные ниже вакансии, пожалуйста, откликнитесь через сервис hh.ru или отправьте нам свое резюме по адресу hr@stentex.ru

Quality Operations &Validation Manager

Exciting opportunity to join a team to establish manufacturing of high-technology medical devices in Russia. Working with an international team, we are seeking an accomplished professional, who will play a key role in the establishment of the Quality Assurance Function, focused on achieving the highest international standards in the manufacture of medical technologies.

DUTIES & RESPONSIBILITIES:
Organizational Leadership
Providing Quality leadership across the value stream that will enhance customer satisfaction, assure regulatory compliance and drive continuous improvement.
Provide leadership, foster team working, coach for performance, mentor for career development and share accountability with the QA management team for the development of a strong pipeline of talent at all levels across the organization.
Contribute to Operations & Quality strategy development and execution to meet key business outcomes
Develop and administer budgets.
Participate as engaged leader and role model in the Stentex Operations and Quality Teams
Ensure that we foster a Quality Culture that promotes, individual accountability, preventative mindset and patient focused behaviors.
Product Quality Control and Regulatory Compliance
Ensure that the quality system in place assures product quality and regulatory compliance by predictably and consistently detecting and correcting deficiencies.
Actively participate in the CAPA Board and enable it’s effectiveness.
Advocate for the awareness of regulatory and customer requirements throughout the organization.
Management of the QC and Lot Release Activities to ensure acceptance and monitoring of material, equipment and environment used throughout the manufacturing process value streams. Maintain operating mechanisms to review and respond to measures per the QPI’s and KPI’s. Membership of the Plant 2 Management team.
Providing Quality leadership to support the various Product value streams within Plant Operations in a state of compliance with respect to Process Validation, Software Validation, Sterilization Validation and Microbiology activities. This encompasses Ops PDP support, sustaining activities such as maintaining Sterilization Validation status as well as improvement projects requiring change to process flow and content and corresponding Process Control Plans. Leadership in this role will require close collaboration with the Engineering teams across the campus for both plant operations and Product Development teams that will enhance customer satisfaction, assure regulatory compliance and drive continuous improvement.
Continuous Improvement
Champion the First Time Quality and Systems Thinking Principles to improve our quality performance
Participate in the innovative application of business process improvement opportunities.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Knowledge of Quality System Regulations (QSR), ISO 9001 standards, ISO 13485:2003, design control, Europe-an MDD regulation and Japan PAL regulation.
Experience in medical device, pharmaceutical or related industry.
Must have an in-depth understanding of quality systems, business process improvement tools, and quality control principles and applications.
Min of a level 8 Degree in Engineering, Sciences or related medical/scientific field is required. Masters preferred.
At least 10 years of relevant quality systems experience and a career history of demonstrated progressive management experience.
Fluent English
QUALIFICATIONS / EXPERIENCE PREFERRED:
Experienced manager with proven leadership skills, multi-tasking skills, process improvement tools (e.g. DRM, six sigma)
SPECIALISED KNOWLEDGE REQUIRED:
Quality systems, quality operations knowledge & design assurance experience
Strong decision making and judgment