Quality Engineer/Greenfield
Okolice Tychów Quality Engineer/Greenfield
Okolice Tychów
NR REF.: 1127771
For our Client - international new greenfield company based near Tychy and Mysłowice, we are looking for Quality Engineer.
Key Comptences:
Required Qualifications:
Offer:
Okolice Tychów
NR REF.: 1127771
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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