quality supervisor/manager in tczew

posted
job type
permanent
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job details

posted
location
tczew, pomorskie
job category
produkcja
job type
permanent
reference number
51139
apply now

job description

Do you want to work in a company that cares?

Do you want to join Greenfield project team in Tczew?

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

Our Client, the Etac Group is a world-leading Scandinavian developer of mobility equipment and solutions. For more than forty years, the Etac Group has developed products and services that creates possibilities for users and carers. All Etac’s products have one thing in common – they are the best in terms of quality, simplicity, functionality, reliability and design that the market has to offer. Etac’s mission is that everyone should be able to live a free and independent life and pursue their dreams regardless of any physical circumstances. Etac offers challenging work experiences in a dynamic and collaborative environment.

If you are interested in being a part of their team, apply to talk with us about new opportunities on the market!

what we offer

  • Being a part of 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

responsibilities

  • 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


Employment Agency - registry number 47