Medline Industries has an immediate opening for a Senior QA Tech at our manufacturing facility in Waukegan, IL. The Sr QA Tech will provide basic QA support to division including complaint investigation & activities, resolution and reporting. Work directly with sales and/or customer regarding product complaints including obtaining details, communicating outcomes, issuing credits/replacements, and implementing solutions.
MAJOR RESPONSIBILITIES:
Review all received information for assigned complaints and reach out to the customer/rep for any missing details required to complete investigation.
Perform product complaint investigation through sample performance testing, image evaluation, historical data analysis and/or other complaint investigation techniques.
Run trending reports of complaints and take appropriate action when trends are identified per SOP.
Document complaint investigations in SAP Complaint System and ensure all logged complaint details are accurate prior to closure.
Compose complaint investigation summary letters to customers and/or reps including any corrective actions completed or recommendations to prevent recurrence if applicable.
Issue credits, replacement orders, and/or RGA's as required for complaint resolution.
Coordinate and track rework, stock checks, and deviations as required in response to complaints.
Work with product managers, other departments within the division, and kit manufacturing facilities for feedback on complaints and for corrective/preventive actions.
Notify kit manufacturing facilities and component manufacturing facilities of non-conformances.
Independently manage workload and prioritize responsibilities to close complaints and complete other tasks within assigned timeliness goals.
Maintain compliance with QST and ISO regulations and Medline policies and procedures.
Education
High School Diploma or equivalent.
Work Experience
At least 2 years of experience in Quality Assurance or Quality Control.
Knowledge / Skills / Abilities
Ability to understand complex products with multiple levels of failure modes and evaluate all details of a reported issue to determine clear and concise conclusions
Experience providing customer service to internal and external customers including meeting quality standards for services and evaluation of customer satisfaction.
Experience controlling and coordinating concurrent tasks, competing priorities, and critical deadlines
Experience with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
Basic knowledge of Quality Systems Regulations and Medical Devices.
Preferred Job Requirements
Experience working through and diffusing difficult situations with internal and external customers.
FDA regulated industry experience.
Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).
