Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
Coordinate and manage the execution of validations and creation of written protocols.
Coordinate and manage the execution of change control activities.
Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.
Utilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards.
Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.
Interact with suppliers and ensures mutual interpretation of specified requirements to make certain customer requirements and objectives are met.
Support implementation and management of quality agreements with assigned suppliers.
Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
Assist the Quality Managers during customer audits and lead to final resolution any findings/observations resulting from the audits.
Assist in maintaining ISO and FDA QSR quality systems compliance.
Execute specific responsibilities as defined within the company quality operating system.
Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
Preferred/Required Education/Skills:
Bachelor's degree in Engineering, Science or related field.
3+ years' of experience in a Quality position strongly preferred.
Experience in the Medical Device industry strongly preferred (ISO13485)
Experience with technical writing, IQ/OQ/PQ is preferred
Experience with equipment validation is preferred
Experience working onsite in Manufacturing is strongly preferred
Excellent communication skills with the ability to understand, read, write and speak English required.
Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
Six-sigma experience, training or certification preferred.
Intermediate level computer skills, including Microsoft Office applications required.