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Tableau, Minitab, Statistica), Ability to establish and maintain effective working relationships with internal team members and external stakeholders, Ability to work with integrity and build trust, Ability to clearly convey ideas and concepts verbally, in writing, and via presentations, Ability to handle multiple priorities and consistently meet deadlines through effective time management skills, A combination of the following education and experience is required: Bachelor’s Degree with a minimum of 9 years related experience in the medical device, pharmaceutical or biopharmaceutical industry OR a Master’s degree with a minimum of 7 years related experience in medical device, pharmaceutical or biopharmaceutical industry OR a PhD with a minimum of 5 years related experience, A degree in Statistics, Chemistry, Biology, Engineering, or other scientific discipline is highly preferred, Experience with Quality Systems, cGMP, and ICH Requirements is required, A strong background in Engineering is preferred, Experience in a regulated industry required, Strong statistical skills are highly preferred, Project management training or experience highly preferred, Excellent technical writing skills; experienced in writing SOPs, protocols, reports required, Master Black Belt or Black belt certification is preferred, Experience in technology transfer/design transfer preferred, Knowledge of Biotech and/or Pharma Manufacturing preferred, Prior participation in cross functional projects preferred, Knowledge and experience with Bayesian methods preferred, Knowledge of QbD, basic manufacturing processes, LEAN, basic automation/IT/lab systems development (i.e., design of experiments) and test processes preferred, The preferred locations for this position are in: Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; or Schaffhausen, Switzerland, but considerations will also be made for the following sites: Malvern, PA; Horsham, PA; Cork, Ireland; Leiden, Netherlands, This position may also require up to 25% domestic and international travel.Quality (Eng), 6 + years experience with a Bachelor's degree or 4 + years experience with a Masters degree, Bachelor’s degree in engineering preferred, Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired. Customer Quality Documentation preparation, Follow up of customer complaints and improvement proposals, Facilitate the Root Cause Analysis of key quality issues for products, Make technical clarification and communication with business Sourcing Quality Engineer and Engineering teams on drawings/specifications and any of quality issues, Take the lead of organizing customer witness inspection at GE Hangzhou site, CTQ (Critical To Quality) Process Capability reporting to internal customer on quarterly basis, Driving reduce cost of quality (COQ), escaping defects, improve DPMO and EHS, Customer Satisfaction Level Survey and related improvement actions for products, Products NCR status reporting and monitoring to ensure its on-time closure, Support of COE IC/WS (Individual Contributor / Work Station) audit and ISO internal audits, Conduct the site audit to find the potential quality risk, and lead to solve it, Quality planning of all machining products, Daily & monthly analysis of rework and rejections along with CFT, Gauge planning & control ( Spares gauges , calibration , downtime reduction), Quality documentation as QAP, check sheet, SOP, FMEA etc, CMM inspection management & review reports, Lead QMS audits & management for Machining CoE, Inspector skill enhancement & team development, New product development ( qualification )from quality front, FAI, In process, sampling & final inspection management & adherence, Ensure high level customer satisfaction by taking actions on customer feedbacks, communication etc, NDT ( MPI / DP / UT ) report review & control, Graduate Engineer BE/B Tech ( Mechanical ) with 6-8 years of experience in machining part quality management, Preferred as NDT Level-II in MT, UT, and DP, Hands on experience on using gauges is essential, CMM inspection experience is highly desired, Six Sigma Training &certification will be preferred, Candidate shall have excellent communication skill, CAPA &Quality Improvement project exposure, Must have worked in shop quality for at least 5 years, Shall have ability to read & understand specifications and drawings & shall have exposure to various machining technology, Hands on inspection on gauge inspection & management, CMM etc, Good exposure on customer quality management, Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Manufacturing), Minimum of 3 additional years of experience in Production Quality, Chemical Engineering, Materials Science, or Ceramics degree, Lead initiatives of moderate scope and impact, Effective problem identification and solution skills, Proven analytical and organizational ability, Coordinates all checking and testing necessary per customer blueprint for sample submission of new programs, Verifies and interprets all blueprint specifications, Completes and submits all supporting customer-required documents for sample submission (including supplier submission from SQE), coordination and approval (Covisant, GQTS, Schedule A, etc), Establishes program FMEA’s, control plans, test and inspection instructions with production personnel, Travels to customer facilities to support program, review problems and report findings to appropriate plant personnel. Assists product and process engineers in the development of new or improved processes that minimize scrap and rework and meet technical guidelines and business requirements, Completes Material Review Board (MRB) disposition on production non-conformances to ensure compliance with internal and customer requirements utilizing knowledge, continuous improvement tools, engineering resources, and assistance of more experienced engineers, Supports production employees, inspection staff, and cell staff by evaluating, interpreting, and providing feedback regarding customer and company requirements and specifications, Support and follow all rules/guidelines/standards set by EHS, Quality, and Continuous Improvement functions as set by leader and position, Performs Quality Assurance for Victoria by performing product test procedures, validating product specifications, performing audits, and leading product reliability improvements via Caterpillar’s Continuous Product Improvement programs, Develops plans and tools to support quality systems and related processes. ... SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link. Coordinate the reporting of Quality KPI's and communicate internally using visual management standards in the area and externally to site management team/stakeholders, Ability to solve problems using Practical Problem Solving Techniques, Experience in standardisation of processes, Understanding and ability to apply in live situations the principles and tools of lean manufacturing, Experience in data analytics, statistical process control (SPC), Robust understanding of Food Safety and Quality Management Systems, Be a key driver of cGMP practices within Operations and Quality divisions, Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems, Responsible for ensuring adherence to all internal and external regulatory requirements, Become an active member of the site internal audit team, liaising with Regulatory auditors, Prepare and maintain documentation in compliance with the appropriate regulatory requirements, Support production personnel in relevant continuous improvement activities (Six Sigma etc. In previous job position sped up the production process by 17%, created 8 QA procedures and 100+ work instructions as well as performed 5S and ISO audit for the company. Reports unsafe conditions to Supervisor/Leader, Bachelor’s degree in technical field of study and/or equivalent work experience ( Metallurgical Engineering or related field is preferred), Strong working knowledge of Quality systems and specifications is required, Ability to write clear and concise technical reports. Be a vocal advocate of customer empathy and risk mitigation, Required Bachelor's Degree in CS or EE with at least 1+ years of experience, Strong Java programming skills (not just writing test scripts), Operate in short Sprint cycles (2-4 weeks) and have experience in the full software lifecycle from design to deployment, Experience working with VMware products and vSphere SDK/API, Strong knowledge of database interface and SQL, Experience in UNIX (Linux/Solaris) administration, Experience in large-scale software deployments, Lead Problem solving activities using Core Tools such as DOE, ERPS, 5Why’s, etc, Disposition of Material Review Board (MRB) in floor shop, Oversees all activities are met under ISO/TS16949 requirements, 3 years of experience in Process Quality and Customer Contact, Knowledgeable on problem solving methodologies and Quality Core Tools, Six Sigma Green Belt (ERPS Knowledge is a plus), Manage team activities ensuring that day to day tasks are on track and maintained, Identifying and promoting procedure improvements & quality best practices, Driving improvements through training and presentations to company staff on quality issues, Initiate and support quality lead investigation (product and process), Utilise problem solving techniques (8D, FMEA, FMECA, HEMEA), Strong problem solving skills (8D, Pareto, 5 Why’s etc. Characteristic Accountability and Verification (CAV) preparation for First Piece Qualification. Create a Resume in Minutes with Professional Resume … ... SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link. Capability to design and draft training materials, document processes and effectively communicate across diverse teams within the Quality and Services and Support organizations, Proven capabilities to project manage Quality System implementations, Ability to work independently, be self-starting and proactive with identifying opportunities for improvement, Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project), Medical Device or Pharmaceutical Regulatory Affairs experience is highly desirable, Bachelor’s degree required, from an accredited higher learning institution, with 5 years related experience, Experience in Quality Engineer or Management Systems is mandatory, Experience in manufacturing of refrigerated products or biomedical assessment of refrigerated products is strongly preferred, Verbal and written communication skills including good persuasion skills are a must, Formal commitment required to obtain ASQ, Certified Quality Engineer Certification, within 24 months of hire, Certified in Six Sigma Black Belt or Shainin Journeyman preferred, Support assembly operations when quality issues arise to maintain production, Manage the rejection process for manufactured product and supplied components, Maintain Reject Database and issue and follow-up on CAR’s/SCAR’s, Run weekly Open Reject / Open CAR Reports, Maintain relative ISO procedures and work instructions, Lead ISO audits and NPD/Engineered projects, Enter issues from audits into PQR database, Work with team members to drive issue resolution, Determine continuous improvement opportunities, Bachelor's Degree in Engineering or Engineering Technology experience and at least 3 years of work experience in a manufacturing environment is required, Ability to communicate at all levels within Residential Solutions Group and with suppliers, etc, Resolution of manufacturing quality issues by utilization of structured problem solving methodologies to establish capable measurement systems, collect and analyze data, identify root cause and implement effective corrective action, Support of quality management system processes and practices including active participation in management of critical to quality processes, Daily quality engineering support of manufacturing operations, Support of new component and new production introduction through development of systems and methods to ensure product and process quality, Lead process improvement activities to improve cost of poor quality, Supplier quality issue resolution specifically related to production operations disruption, Completion of PPAP and process capability assessments, Bachelors' degree in Engineering or closely-related field required, Quality Engineering certification is a plus, Experience with implementation of Quality Management Systems is a plus, 5+ years of experience in a manufacturing operation technical support or leadership role, Demonstrated experience with leading structured problem solving activities, Proven ability to apply Lean Six Sigma tools, Leading and executing quality improvement projects, Respond to customer complaints with root cause analysis, and initiate follow-up improvements and control plans to prevent recurrence, Support customer audits by completing requested information and completing on-site audit activities, Participate in daily Lean Manufacturing improvement efforts, Complete MSAs for new test procedures and updated as required, Lead supplier management activities including but not limited to on-site audits, quarterly TQRDC and supplier review, Monitor statistical process control charts, Support the ISO-9001 Certified Quality Management System, Monitoring product process capability by appropriate index i.e.

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