Performs timely incoming inspection and inspection plan creation of purchased finished goods received at the warehouse per established methods.
Creates timely nonconforming records for failed inspections or final release activities.
Created inspection plans for incoming inspections and updated work instructions.
Creates engineering changes and ensures inspection planning requirements are met.
Responsible for meeting departmental metrics.
Manages daily management board data and may lead meetings.
Responsible for champion lean initiatives and continuous improvement.
Escalates issues to direct manager.
Generates departmental metrics and reports to management.
Completes work with a limited degree to no direct supervision.
Developing professional expertise, applying company policies and procedures to resolve a variety of issues for direct area of responsibility.
Likely to act as an informal resource for colleagues with less experience.
Developed professional expertise, applies company policies and procedures to resolve a variety of issues for direct area of responsibility.
Has developed specialized skills and is multi-skilled through job related training and considerable on the job training/experience.• organizational, interpersonal skills required.
Technical writing, communication, and organizational, interpersonal skills required.
Experience & Background
Able to complete set-up and inspections with a coordinate measuring machine and other inspection tools as necessary.
Test Method Validations (TMV) knowledge.
Past measuring equipment experience.
First Article experience.
SAP (MRP/ERP) experience desired.
Able to read and understand drawing requirements and tolerances.
2 years of experience in the medical device industry required.
Prior experience in working in a manufacturing or warehouse related environment, required.
Basic understanding of CAPA, as well as global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and EU MDR.