Senior Manager, Manufacturing

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The Interventional Urology Senior Manufacturing Manager will lead the Manufacturing teams and be responsible for managing daily manufacturing operations to maintain high quality and safety levels, obtain maximum efficiency and meet performance and financial objectives.   This role will ensure compliance with all local, national, and international applicable regulations.  In addition, this position will be responsible for troubleshooting problems, taking corrective and preventive actions, driving continuous improvement activities, and developing employees.

 

Major Areas of Accountability

• Management
  • Develop and deliver on strategies to improve efficiency, effectiveness, and compliance
  • Develop, organize, and lead a team capable of maintaining and improving the needs in manufacturing and operations
  • Directly or indirectly manage employees involved in planning & execution of manufacturing activities and operations
  • Ensure employee development and morale is a key focus; provide/propose training for new hires and existing employees to ensure appropriate skill level is maintained and in compliance with applicable regulations.
  • Partner with cross-functional departments on project support, problem resolution, initiatives, and improvements; address and resolve business system issues with IT as needed.
  • Interpret company policies for workers and enforce safety regulations; maintain compliance with Hazardous Waste / Chemical handling procedures and OSHA Forklift training.
  • Assure company policies are communicated, implemented, and enforced in alignment with Coloplast Leadership Principles and Mission, Vision and Vision.
• Manufacturing
  • Work with production planner to translate monthly build plan into weekly/daily schedules and work with supervisor to adjust work schedules to meet production requirements.
  • Drive continuous improvement in manufacturing by utilizing Lean and/or Six Sigma techniques and gather/analyze data to make improvement decisions on processes, equipment performance and/or quality of product;
  • Establish production goals and objectives to meet current demand; analyze capacity requirements with Engineering and Enterprise Excellence to meet future demand.
  • Maintain compliance and satisfy quality requirements for all product manufactured on-site.
  • Manage department forecasts and budgets to deliver expected financial results.
  • Implement corrective and preventive action activities as needed to address shortcomings in manufacturing.
  • Lead cycle count activities within the team, maintain cycle count accuracy reports.  Communicate cycle count activities as requested by Finance team supporting periodic inventory audits.
  • Participate in safety committee and quarterly environmental management reviews.
• General
  • Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
  • Other duties as assigned

 

 

Essential Qualifications

• Bachelor's degree (B.A./ B.S.)
• 10+ years experience in operations leadership, with 5+ years’ experience leading teams
• Work experience in FDA-regulated industry, medical device strongly preferred
• Experience improving manufacturing operations using Lean, Six Sigma and/or CI techniques; certification is preferred
• Experience with MES or other systems to track and analyze production operations
• Strong team leadership, relationship building and the ability to work cross-functionally
• Ability to organize and manage multiple priorities with a high degree of accuracy, be self-motivated and possess the ability to work independently.
• Willingness to be on call for