Do you want to work in a company that cares, developing products that help people improve their quality of life? 

Do you want to join a greenfield project team in Tczew?

The Etac Group is a world-leading developer of ergonomic products that assist people living with restricted mobility. Founded in 1973 by RFSU, Etac is today owned by Nordstjernan, a family controlled unlisted investment company. 

Our mission is that everyone should be able to live a free and independent life and pursue their dreams regardless of any physical circumstances. We offer challenging work experiences in a dynamic and collaborative environment. For our employees, work is more than just a job - we are passionate about working in a company developing products that help people improve their quality of life.

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The offering

  • Being a part of a greenfield project
  • Working in the best in class site 
  • International environment and Scandinavian culture
  • Innovative solutions  

Your tasks

  • Implement, manage, improve and maintain the Quality Management System (ISO 13485, ISO 14001) across the organization
  • Develop and initiate procedures, guidelines and methods for inspection, testing and quality control
  • Actively participate in all internal and external auditing activities and follow-ups
  • Plan, define and direct the site auditing control program to ensure compliance to all procedures, and policies
  • Ensure quality and compliance of the products manufactured with internal standards and specifications
  • Continuously monitors process performance and action effectiveness, identifying needs and opportunities for improvement
  • Data collection, trending and management of statistical methods
  • Actively support new supplier’s evaluation process
  • Maintain quality standards for production processes, materials and products
  • Coordinate and manage preventive/corrective actions and continuous improvement initiatives
  • Motivate and deliver training to the organization on topics related to Quality Management
  • Train, mentor and lead site QA and Production team to insure set goals are met
  • Exert the role of Management Representative and assure, control and report Quality KPI’s targets
  • Review computerized system validation for Good Manufacturing Practice (GMP) systems
  • Supervise product release, design transfer and review/approve Device Master Record (DMR) and Device History Record (DHR) documentation
  • Conduct process validation and risk management Process Failure Mode and Effects Analysis (PFMEA)
  • Support change management process regarding new products, procedures and standards
  • Support NPI process from an operational perspective, ensuring quality compliance to regulatory and laws
  • Operate in line with company policies and procedures with focus on quality management system, company ethic & culture and harmonization with Group Compliance programs
  • Work with the Company’s health, safety and environment rules & policies

What we expect

  • 5 years of experience in relevant position
  • Direct or indirect experience from medical device industry, pharmaceutical or similar will be a strong asset
  • Bachelor degree in engineering, life science or equivalent
  • International company work environment experience
  • Advanced knowledge of quality systems, GMP procedures, & policies
  • Quality systems implementation skills & experience
  • Product & process audit skills
  • Supplier evaluation process skills
  • Knowledge of analytical and statistical processes
  • Non-prestigious, social and effective communication skills
  • Planning and organizing skills
  • Knowledge and experience in standards and regulatory demands
  • English – advanced
  • ERP systems (preferably Movex) & MS Office package knowledge
  • Result & solution oriented and structured
  • Cooperative team-player who drives results and takes responsibility in influencing others
  • Flexible and open to new ideas and new ways of working
  • Solution-oriented and structured
  • Able to communicate efficiently with different stakeholders
  • Ability to work in a changing environment
  • Strong administrative skills