Quality Engineer/Greenfield
HAYS POLAND Sp. z o.o.
Tychów
‎17 godz. temu
source : Jobs.pl

For our Client - international new greenfield company based near Tychy and Mysłowice, we are looking for Quality Engineer.

Key Comptences :

  • Support the development, implementation and maintenance of a robust quality system in accordance with ISO 13485 and 21 CFR 820 requirements
  • Participate in manufacturing quality activities, including receiving / in-process inspection
  • Support data analysis and metric / management review activities
  • Support change control, design control and risk management activities
  • Support product development activities including test programs and product builds
  • Cordinate CAPA, NC’s and Customer Complaints. Participate in Root Cause Analysis.
  • Initiate, recommend or provide solutions to product and Quality system related problems.
  • Participate in internal / external audits as required.
  • Ensure that preventive and corrective actions are taken in relation to product and Quality system deficiencies.
  • Interface with other departments to ensure that Quality system requirements are adhered to.
  • Coordinate new process techniques that improve overall job efficiencies
  • Implement systems and procedures that assure compliance with Quality Standards
  • Development and implementation of statistical incoming and in-process sampling / control plans
  • Support the qualification of processes performed by suppliers; troubleshoot and lead corrective actions relating to supplier performance;
  • improve process for supplier data submission to reduce internal inspections

  • Responsible for being a communication liaison between the customer and manufacturing facility
  • Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Lead development and review of validation plans and protocols
  • Measure validation process effectiveness and lead continual improvement of system
  • Communicate and coordinate activities including internal and external approvals of validations
  • Extended travel to other facilities may be required to support business needs
  • Required Qualifications :

  • Bachelor’s Degree in an engineering / science field
  • 3+ years of quality / regulatory experience
  • Auditing experience preferredUnderstanding of regulated product manufacturing process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from a group of managers, sales, and customers
  • Strong verbal and written communication, teamwork, and organizational skills
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve customer satisfaction
  • Demonstrable track record within an regulated product quality system
  • Demonstrable track record of planning activities with contingency actions
  • Offer :

  • possibility to develop in new structures
  • international team
  • benefits
  • greenfield project
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