Role Summary/Purpose Within the GSC Operational Excellence team, the Manufacturing Project Leader will be responsible for developing a reliable wing to wing supply chain in China & Asia region, including new suppliers, manufacturing processes and manufacturing capabilities, in accordance with our project management template PRDx and with tangible customer outcome. Supported by a solid business cases, he/she will execute the GSC strategy in region for region, he/she will be intensively engaged in product and operation development projects. He/she will assess resource requirements, supply chain risks, and operational capabilities required, including supplier capability assessment, in order to develop a strong manufacturing base in region for region, with a robust hand-off between GEHC engineering and our suppliers.
Essential Responsibilities • Early engage with Product Management, R&D, site manufacturing engineering and supplier capability engineering to enable successful technical transfers into manufacturing and/or suppliers. • Effectively assess and evaluate supplier capabilities used in the supplier selection process. • Improve supplier quality performance for assigned suppliers/parts via Quality Plan Implementation. • Develop positive relationships and work closely with Global Sourcing Leaders and Modality Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers. • Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive quality improvements that minimize the Costs of Quality, specifically Failed on Arrival/Install (FOA/FOI) issues, Field Failures, and Factory defects. • Develop hands-on expertise locally in the bioprocessing consumables manufacturing. • As GSC local owner and project catcher for technical transfer products from global manufacturing to China, and sign off the new manufacturing line built in China from GSC perspective. • Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process. • Lead a cross-functional Program, including Sourcing, Manufacturing, Product Quality, Materials, to achieve targets of Operation deployment in Region for region. • Seek early understanding of Standard Product Cost, EHS risks, Regulatory Risks, and training needs. Plan activities to address these needs in timely manner. • Lead accurate and timely completion of documents required for each Milestone Review. This includes Supply Chain Strategy, Design Transfer Plan, Supply Chain Readiness Report, Validation Plan. • Highlight Supply Chain Risks related to Safety, Cost, Lead Time, Business Continuity and Regulatory Compliance to Project Management and Leadership Team. Follow through on Risk Mitigation Activities and provide status updates in Program Reviews. • Driving LEAN manufacturing implementation • Ensure sound Project Administration through resource plans, meetings minutes and actions-decisions log, and Project Archives. • Design and develop new processes to support both short and long term business plans with productivity, capacity and quality improvements. • Lead Compliance, as well as Environmental, Health & Safety efforts in support of plant goals • Provide safe processes that comply with all local and federal regulations. Assure that corrective action is taken to resolve observed safety concerns in all areas.
Quality Specific Goals: • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. • Complete all planned Quality & Compliance training within the defined deadlines. • Identify and report any quality or compliance concerns and take immediate corrective action as required. • Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements.
Qualifications/Requirements • Bachelors of Science in Engineering or related field (Science) or equivalent knowledge or experience • Experiences with polymers/plastics in the bioprocessing or medical device industry • Significant experience in product and/or process development • Excellent problem-solving abilities using analytical and logical thinking skills • Previous experience in leading projects including managing scope, budget, quality. • Understanding of QA-QC and testing procedures. • Good analytical and planning skills. • Strong Six Sigma skills in DMAIC and DFSS, Minimum GB Certified • Working knowledge of Lean tools and Lean thinking. • Solid working knowledge of GEHC QMS procedures for Design Controls and Design Transfer • Good leadership skills and proven ability to manage effective global direct and dotted line teams and operating mechanisms. • Strong Influencing skills. Resourceful and Inclusive. Comfortable working thru pushback. • Strong communication Skills, written and verbal. • Willing to travel internationally and domestically up to 25% of the time
Quality Specific Goals: • Maintain awareness of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and • regulations as they apply to this job type/position • Complete all planned Quality & Compliance training within the defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Maintain Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) • Timely complaint handling and reporting • Timely review of documentation and records • Accurate quality data reporting and signal response • Provide objective evidence of global processes through compliant documentation