The main responsibility of the Quality Engineer III is to ensure strict adherence and a commitment to corporate and / or local policies, rules, and regulations through the establishment and maintenance of an effective Quality Management System.
An employee in this position must focus on customers' expectations (both internal and external) and strive for continuous improvement.
The Quality Engineer II will support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality polices and procedures, and relevant regulatory requirements and industry guidance, including :
Document control and review / approval of controlled documents
Change management and review of change controls
Investigation and CAPA management, including robust root cause analysis
Complaint management and performance of complaint investigations
Supplier quality management and performance of supplier audits as appropriate
Internal audit program and performance of internal audits
Lead and / or support the oversight of product realization and commercial manufacturing activities, such as product / specification development, tech transfer, validation, process capability, facilities / utilities / equipment qualification and maintenance, and materials management.
Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.
Qualifications : Education :
A minimum of a Bachelor’ degree in Engineering, Informational Systems or Computer Science is required.
Five (5) to eight (8) years of related experience in Medical Devices, Consumer and / or Pharmaceutical environment is required.
Skills and experience
In depth knowledge of FDA guidelines pertaining to Validation is highly preferred (IQ,OQ, PQ, TMV).
Experience working within the QA Function and systems validations is preferred.
Knowledge of Process Failure Mode Effects Analysis, Risk assessment, Failure Investigations and Problem solving is highly preferred.
Proficiency in MS Excel is required.
Experience working with Minitab is highly preferred.
Computer skills and use of software application(s) is required.
Fully Bilingual (Spanish & English) is required, excellent communication and interpersonal relation skills
Experience in Quality Department.
Demonstrated knowledge and experience on applied statistics, green belt certification preferable.
Able to work extra hours, at night or on week-ends and irregular shifts to support business needs.
Solid project management skills.