Quality

Job Description:
• Contribute to continuous improvements in overall product cost and quality. • Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. • Maintain documentation associated with packaging/manufacturing processes. • Provide technical support for production packaging/labeling tools and software including assembly/sealing equipment and automation. • Follow established guidelines and management direction with regard to engineering decisions. • Advise leadership of developments which may affect schedule and costs. • Participate on projects to concurrently develop packaging assembly methods, tooling, equipment and processes for new and existing products. • Partner with Manufacturing to develop lean principals to implement solutions for product packaging, labeling and sealing/assembly. • Create standardized work and process maps that result in an optimized production system and extended value stream. • Conduct, coordinate and aid in formal Process Validations including protocol development and execution. • Support line validation / qualification activities for including IQ, OQ , MSA and PQ • Support project team members in achieving business objects related attainment of Safety, Quality, Service, and Project Schedule and Cost goals. • Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. • Interactions with manufacturing providing hands-on support and responsibility for metrics such as labor time, lead-time, capability, and yield. • Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA. • Perform root Cause Analysis (RCA), NCR and CAPA responses. • Complete on time project updates, development plans, self-assessments, and successful completion of all training requirements. • Application of statistical and analytical methods such as SPC, SQC and DOE. • Contributor to the Capital Expense Request (CER) process, specify cost for packaging/labeling/sealing equipment with consideration to product standard cost targets and capacity demands. Skills: • Strong leadership skills and able to take direction • Knowledge of Lean and/or 6 Sigma • Knowledge of GD&T • Knowledge of DFMEA and PFMEA • Strong Interpersonal Skills • Strong Computer Skills • Strong Project Skills • Knowledge and Experience with packaging, assembly and manufacturing methods/equipment (ie: Sencorp bar sealers, Alloyd blister sealers and material sealing of PETG to tyvek, foil to tyvek, foil to foil, mylar to Tyvek) and Vision Systems. • Knowledge and Experience with packaging material process and testing.
• Engineering and Problem solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC • Experience with DFMA and Lean manufacturing tools. • Excellent organization, Planning, Computer skills, Technical writing, Communication and Presentation skills.
Qualification:
• B.E - Mechanical Engineering/Industrial Engineering