Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical Devices, ManufacturingIndustries
Requirements
One-year certificate from college or technical school preferred
Three to six months of related experience and/or training preferred
Equivalent combination of education and experience will also be considered
Ability to perform functions in a SAP & Microsoft Environment
Good verbal and written communication skills
Ability to add, subtract, multiply, and divide in all units of measure
Responsibilities
Supports the company's Quality Policy, Mission Statement, and ISO Quality System
Manages reports any employee feedback regarding the execution of job duties
Identifies problems, seeks resolution, and brings any remaining issues to management's attention
Supports and maintains a team environment by providing day-to-day leadership and motivation
Ensures safety awareness and adherence to all safety policies
Conducts product inspection of Device Master Record
Performs scheduled raw material inspections in compliance with MAI Standard Operating Procedures, which may include the use of calibrated measuring devices
Oversees finished goods, Returned Goods Authorization (RGA), Non-Conforming Material Report (NCMR)/SCARS, and damaged product processes, (COD) Notice of Destruction
Determines the disposition of damaged and/or expired products, including any possible recoup
Supports product recall/Vendor return process through physical identification and segregation of product
Supports the Quality Engineering Department with investigations regarding reported Vendor issues, determine how to resolve problems, and implement the solution
Prepares data for analysis and presentation by others
Generates and manipulates Excel Spreadsheets for analysis and reporting purposes
Assists with scheduled specification reviews and ensures that the latest revision of specifications is maintained and referenced
Performs scheduled finished goods and raw material inspections in compliance with MAI Standard Operating Procedures, which may include the use of calibrated measuring devices
Maintains sample history files for all received artwork
Maintains records of all inspection results and acceptance and rejection activities in the Enterprise Resource Planning (ERP) system and incoming inspection folders
Ensures non-conforming materials are placed on hold by the MAI Standard Operating Procedure and documents disposition in the ERP system
Communicates product failures to QA Management
Communicates suggestions for improvements in reducing costs and improving quality and customer service
Maintains Calibration documentation in electronic and hard copy files, including scheduling, printing, and closing orders
Ensures support to the 2nd shift Teammates with being proper trained with non-conforming products and assembly
Conducts in-process audits of manufactured goods and/or inspects purchased finished goods and raw materials for compliance with specifications
Maintains and reports audit and inspection results