Provide support to ensure product is manufactured by following documented procedures and confirming these procedures meet customer specifications and industry standards
Collects data and prepares reports associated to quality performance on a daily/weekly basis
Conduct FAI for new products and/or Engineering changes
Participate in the evaluation/release of ECOs
Provide Quality criteria following customer/industry requirements
Liaise with customer Regulatory Affairs team on documentation deliverables and timelines
Update Quality documents as required
Support internal, industry and customer audits as required
Conduct audits to the production line to ensure processes are being properly followed
Occasional overnight travel for work-related duties
Requirements
7 to 10 years of related experience
Experience in similar job roles
High School Graduation. G.E.D. (or equivalent) (HR to verify if Technical Diploma is required)
Strong knowledge of Microsoft Word, Excel, SAP, Power Point
Ability to analyze data to identify trends, create pareto's, histograms
Knowledge of the manufacturing process
Ability to evaluate and prioritize a variety of tasks to ensure timely and accurate completion
Good analytical and problem solving skills following 8D methodology
Ability to conduct audits to the production line to ensure processes are properly followed
Occasional overnight travel may be required
Physical ability for sitting/standing, walking and sustained visual concentration on small areas