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
possibility to develop in new structures