Investigates, analyzes and resolves supplier quality issues by conducting audits, manufacturing line assessments, analyzing defect trends and leading continuous improvement projects.
Will use quality engineering principles and techniques to assigned business problems related to supplier performance by monitors and evaluates supplier metrics to ensure that the results meet established needs and goals.
This role will be a partner in developing key suppliers to meet our stringent quality requirements.Work closely with Receiving Inspection personnel to provide any engineering support required.
Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary.
Problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of defects.
Utilizing process improvement tools to drive process and product quality.
Monitoring supplier quality levels and perform development activities with strategic suppliers to insure quality performance goals are met.
Process qualification - ensure supplier adherence to Work Instructions, Process Control Plans, Engineering Drawings and Specifications.
Initiate action at the RI lab or manufacturing lines to prevent the occurrence of any non conformities relating to product, process, and quality systems.
Experience working with suppliers on medical product quality issues.
Solid understanding of receiving inspection and finish product release processes including statistical sampling, component measurement techniques, specifications, sterilization and drawings.
Understanding of CAPA and closed loop corrective actions.
Strong attention to detail.
Excellent verbal and written communication skills.
Proven ability to multi-task and effectively manage multiple priorities and deadlines.
Ability to work independently in a fast-paced environment
Bachelor’s Degree in related field, advanced degree preferred
Medical device industry experience preferred.
Good communication skills, both written and oral.
80% English proficiency both written and verbal.