Principal Process Engineer/ Sr. Manager Agile Search Inc -
Billerica, MA
Our client is a global life-sciences firm with diverse products spanning medical devices, diagnostics, and biopharmaceuticals.
In this role as a Process Excellence Principal Engineer, you will lead the development and implementation of Quality relevant con cepts, techniques, processes, and systems . The Principal must have the ability to drive innovative improvements from concept to implementation throughout a complex global organization. Specific requirements of the position include at minimum:
Subject matter expert for applied Lean, Six Sigma , and Continuous Improvement Extensive working knowledge of Quality by Design (QbD), Design Space methodology, Design Control, Design for Six Sigma, and staged product development process es Extensive working knowledge of manufacturing process validation Extensive working knowledge o f manufacturing process control including SPC, LIMS, and other ma nufacturing intelligence tools Applied w orking knowledge of all aspects of Quality Management including Quality Management Systems, Quality Engineering, Quality Assurance and Compliance, Operations/Manufacturing Quality, and Regulatory Affairs Must have demonstrated the above requirements within a regulated industry (pharmaceutical and/or medical device)
Position Responsibilities:
L ead the adoption of Quality by Design from concept, pilot, through global implementation Lead the improvement of manufacturing process control across manufacturing operations Lead the improvement of process validation strategy, policy, procedure, and tools throughout the company Align and i ntegrate Quality relevant continuous improvement strategies and activities with Lean & Six Sigma functions with in the organization Lead Quality relevant global continuous improvement programs Serve as Lean & Six Sigma subject matter expert for the organization . This may incl ude providing training on the following concepts: Root cause analysis Problem solving Risk management DMAIC Drive other continuous improvement programs including: Regulatory Affairs process management Quality systems process management Assist in the development of the Global NPI ( new product introduction ) G overnance process Lead global Cost of Quality improvements Support acquisition/due diligence activities by providing expert evaluation of quality management systems, processes, and requirements
Other Requirements:
10+ years of leading continuous improvement programs from concept through implementation and monitoring. The programs must have been implemented globally across multip le locations and business units AND the programs must have demonstrated effective sustainable results. 10+ years of certified six sigma Black Belt or Master Black Belt Bachelors degree in a technical discipline Strong working knowledge of quality and regulatory requirements ( domestic and international ) , including current industry interpretation. The ability lead trans formative change across an organization The ability to leverage and navigate the organizational matrix Effective communication, management, and leadership skills which can be applied to an executive board room meeting or a manufacturing shift meeting
Monster - 10 months ago
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