Quality Engineer II

Quality Engineer II

PRIMARY PURPOSE SUMMARY A Quality Engineer / Product Owner is responsible for the "end to end" quality system management for customer products. This ownership includes the development, supply, manufacturing, and customer-use related to Quality deliverables. This ownership model will be integrated with the overarching Aptar Quality Management System. High level responsibilities will include, but not limited to, establishing customer specifications, developing quality assurance systems for production environments, developing systems for Quality monitoring and trend reporting, driving scrap and hold reductions, educating both Production and Quality personnel on customer requirements and inspection methods, working directly with customer points of contact on Quality defects and providing on-site support for these defects, and escalating Quality defects to management and providing solutions for correction/prevention.

DETAILED DESCRIPTION Primary Duties & Responsibilities Participate in New Product initiatives and develop customer specifications. Manage product holds, creating sampling plans, and disposition instructions. Manage COAs for product shipments. Perform Bioburden and Environmental monitoring sampling. Create customer relationships for Quality related functions (complaints, defect reporting, quarterly visits). Manage customer complaints to resolution. Manage customer complaints via ETQ Reliance. Support Quality Lab equipment: CMM, Force gauges, calipers, micrometers, etc. Create Sample request for new products or change requests. Participate and lead Reselection/Rework initiatives. Coordinate with Regulatory groups for customer requests, and where applicable, use TraceGains. Suggest, lead, and participate in Continuous Improvement projects (QRQCs). Complete end-of-month budgetary reporting for internal and customer accruals related to Quality. Support Document Control & Monitoring and Calibration equipment initiatives. Support departmental annual objectives. Facilitate and lead on-site customer audits. Participates in regular one-on-ones, task delegation, coaching/mentoring programs, and constructive feedback methodologies. Support and lead PFMEA, MSA, PPAP, SPC, & DOEs. Suggests opportunities for system improvement and works as a team to drive improvements. Support and adhere to all system procedures and Company policies / procedures. Maintain a clean and safe work environment. Follow all safety regulations. Participate in other tasks as assigned

Qualifications Education BS degree in Engineering, Quality Management, Business Administration preferred or equivalent experience and relevant certifications ASQ CSSBB, CQE, CQM/OE preferred Experience 5 years' of experience as a Quality, Manufacturing or Industrial Engineer is preferred but less than 5 may be considered based on other relevant experiance and/or education/certifications. High proficiency in computer technology and systems operation, experience with SAP, Minitab, Microsoft Suite (Excel, Word, PowerPoint) required Experience interacting with customers via phone, email, and face to face preferred Working knowledge of the ISO:9000 and SQF standards and requirements preferred, some knowledge required Black or Green Belt/Six Sigma certified and experience in continuous improvement activities such as Kaizen preferred Skills Experience with developing and presenting a "story" regarding a defect (timelines, events, notes) which clearly communicates the issues to Management and others. Extensive experience in a quality assurance environment preferred Strong analytical and problem-solving skills Excellent written and verbal communication skills. Broad skill set in customer negotiation preferred Ability to motivate and lead improvement in areas of responsibility Working knowledge of Root Cause investigation utilizing Quality tools, 5 Why, Ishikawa diagram, DMAIC, statistical analysis. Ability to build and maintain relationships in a manufacturing environment. Ability to work independently, resolve conflicts and drive customer satisfaction. Professional and optimistic attitude, ability to work in a team environment. Overview of Competencies by Cluster ISO Lead Auditor SQF and HACCP Lead Auditor Capable of setting up and running DOE's ASQC Certified Quality Engineer Effective written, verbal, and sales presentation skills Authority Limits Budget Approval Amount Legal Other Requirements Travel as necessary (up to 25%).