External Manufacturing Organization


Date: 07/23/2020

Location: Indianola, PA


The primary responsibilities of this role, External Manufacturing Organization (EMO) Lead Americas, are to: 


  • Lead the interaction between Global internal functions, sites and external Medical Devices Contract Manufacturing Organization (CMO’s) throughout product lifecycle to ensure transparency, aligned objectives, and efficiency between the functions of both companies;
  • Provide strong Medical Device Operations expertise in diverse areas including new equipment specification, process validation, test method development, design of experiments, new technology introduction, continuous improvement of supplier processes, capabilities, mfg. equipment technologies;
  • Provide input/guidance into resolution of production issues/deviations to ensure continuity of supply;
  • Ensure that all product and process non-conformances are resolved in a robust, closedloop manner, internally, at the CMO and across the supply chain;
  • Hold CMO’s and cross-functional stakeholders (Development, Life Cycle Engineering (LCE), Supplier Quality Engineer (SQE), Supply Chain Management (SCM), etc.) accountable for their respective deliverables;
  • Implement process and product changes at CMOs (e.g. qualification of new sources of raw materials, design and process changes, new molds, new equipment specification, testing and validations, etc.);
  • Identify, manage and successful deploy of key continuous improvement projects around the principles of operational excellence to drive value out of the External Manufacturing organizations and network (e.g. cost savings, performance improvement, capital investments, new technologies, automation, line optimization, etc.);
  • Support Senior External Manufacturer Project Managers to drive completion of activities or act as Project Lead for assigned transfer projects at CMOs;
  • Be accountable for ensuring the CMO has adequate capacity to support product launch and growth (facilities, capital equipment, resources);
  • Prepare and provide input into the annual maintenance or Sustaining capital budget and manage Investment Plans appropriately based on Long Term Supply Planning strategy and Product Roadmap;
  • Work collaboratively with Commercial Quality organization and Life Cycle Management to monitor customer complaints and product returns in order to identify any adverse trends;
  • Drive corrective and preventative actions into manufacturing processes at the CMO’s and/or product design in order to improve the customer experience and/or ensure product compliance;
  • Be accountable for ensuring the External Manufacturing environment and the CMO sites are conducive to product quality (GMP) and are adherent to Sustainable Manufacturing practices (green and safe).

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