AESCULAP, INC. Senior QA Packaging Label Engineer in Hazelwood, Missouri

Aesculap Inc.Requisition ID 2018-12871Company Aesculap Inc# of Openings 1Job Locations US-MO-HazelwoodCategory QualityPosition Type Regular Full-TimeShift 8am -5 pmSite AesculapOverviewAesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients' lives.ResponsibilitiesPosition Summary:Be part of a dynamic quality organization supporting Packaging and Labeling for new product development/sustaining efforts. The Senior QA Packaging Label Engineer has technical responsibility for creation, verification, and controls of packaging and labels for products distributed by Aesculap.Responsibilities: Essential DutiesProvide label and packaging design and technical support to new product teams (create/execute protocols for packaging validations, to ensure confidence of the intended distribution methods).Partner with cross-functional teams as the packaging and labeling expert, and represent the team at the department level.Facilitate Quality and Regulatory representation, to provide packaging input to product submissions and demonstrate a good understanding of Medical Devices labeling regulatory requirements.Create and maintain label control methods (master files, change control with appropriate approvals, work instructions, training).Work collaboratively with SAP experts for creation and controls of labels residing in SAP system.Provide printer and labeling support for issues observed in manufacturing and demonstrate systematic problem-solving expertise to resolve.Identify all packaging requirements, establish guidelines for success, and train/mentor teams through the packaging process with a view to improving the overall in-house awareness of the key principles and standards.Main point of contact for internal and external audits/inspections.Participate in CAPA and Internal Audit activities.Supports complaint and NCR investigations for issues related to packaging and labeling.Supports other Quality related activities as assigned.Acts as informal resource for colleagues with less experience.Must comply with applicable ISO and FDA regulations as stated in Quality ManualMust embody the Company's Vision, Mission and ValuesOther duties may be assignedExpertise: Knowledge and SkillsLanguage Skills: Ability to read, analyze, and interpret risk documents, product operating and maintenance instructions, and procedure manuals. Ability to write technical reports and correspondence. Ability to respond to common inquiries from customers, regulatory agencies, or members of the business community. Ability to speak effectively before employees of organization.Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to perform statistical analysis of data sets to verify acceptance of measured data per protocol requirements.Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.QualificationsExpertise: Qualifications - Experience/Training/Education/EtcRequired:B.S. in Packaging or related engineering field.Requires 5+ years experience with packaging and label design or process environment in a regulated industry such as Pharma/Medical Devices or other regulated industry experience will be considered.Knowledgeable in ISO, ASTM, ISTA standards and test methods related to packagingRequires high level of attention to detail, and pro