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Engineer,Advanced Quality

JOB SUMMARY:
The AdvancedQuality Engineer leads product development quality initiatives throughidentifying, investigating, planning and conducting activities aimed atinsuring robust and quality design and manufacturability of medical devices andcomponents during development. Is responsible to bridge the gap betweenproduct engineering, production, supply chain and quality with respect toquality improvements, compliance and cost management.
ESSENTIAL/PRIMARYDUTIES:
Plan, lead and manage quality deliverables on product developmentprojects
Responsible to ensure that the design, and design changes,complies with all specified regulatory agencies. (FDA, ISO, UL, CSA, etc.)
Daily involvement in making decisions and/or providing technicaldata for decisions that impact compliance with design specifications.
Internally communicate with Engineering,Purchasing, Program Management and Product Engineering on opportunities forquality improvement
Perform or lead root cause analysis on part orproduct quality issues during early launch
Assist in the development of dimensional controlstrategies
Managing risk analysis through such tools as FMEAs, DOEs,capability analysis, etc.
Ensure that customer requirements areincorporated into product functional specifications and lead risk and failureanalysis (U,D&PFMEA) to ensure functional specification requirements arefully met during process/design validation
Review manufacturing processes, collaborate onprocess improvement and value enhancement opportunities.
Coordinate with Supplier Quality the integrationof customer requirements to the supply chain
Participate in Item Qualification/Commercialization activitiesfrom protocol development, to testing, to a completed final report.
Internally escalate potential product/processquality issues and develop a plan with suppliers to resolve
Develop, track and report out on qualityprogress for development projects
Provide technical and administrative support asneeded.
Assist in the design, procurement, andqualification of gages and instruments
Integrate Program lessons learned in APQPactivities
Perform work in accordance with IS14971 andISO13485 standards
SECONDARYDUTIES:
Midmark Production System (MPS) concepts to identify and eliminatenon-value added tasks and/or activities in the various areas of responsibility.
Actively involved in creating documents related to engineeringfunction. Documentation includes, but not limited to, layout drawings,detail drawings, assembly drawings, Bill of Materials, Change Orders, productand component test specifications and design records
Actively lead or participate as a member of product research teamsto acquire detailed product and user knowledge.
Design and analyze complex parts and assemblies to applicablespecifications. Parts include, but not limited to, Sheet Metal, PlasticInjection Molded, Plastic Vacuum Formed, Aluminum Die cast, Steel Sand cast,and Weldments.
Perform statistical analysis of all design and development datarelated to quality design and development; collect, interpret, develop SPClimits and organize results
EDUCATION and/orEXPERIENCE:
Bachelor Degree in Engineering or associated fields, or equivalentindustry experience.
2+ years experience in Quality Assurance, including Qualitysystems, standards, metrics, and tools.
2+ years of experience in the medical device industry
Understanding of medical device quality systems and applicationsis desired.
Ability to effectively influence and negotiate with all levels ofan organization and leading effective/successful change initiatives.
COMPETENCY/SKILLREQUIREMENTS:
Certified Quality Engineer (CQE) /Certified Quality Auditor (CQA) preferred.
Mastery of software programs -Microsoft Word, PowerPoint, Excel, Project, Minitab.
Strong written and verbal communication skills
Knowledge of FDA and ISO regulations



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