Position

Sector / Department

Lean Six Sigma Manager

Operations

Develop & Lead conversion of mass production systems to Lean production systems

•    Develop, lead and facilitate ongoing Kaizen Events

•    Facilitate six sigma green belt & black belt candidates & projects

•    Lead the implementation of automated SPC management system

•    Lead the development of SPC implementation across product families

•    Train plant team in Lean Production System ideas and systems

•    Provide leadership to ensure the seamless coordination, execution and integration and establishment of a Lean Six Sigma Culture in the manufacturing location by driving synergies (processes, resources, best practices).

•    Lead the development of the LEAN Six Sigma Program to improve business results, capability, communications, training, information sharing, flexibility, and speed to market across all functions at the Plant level.

•    Streamline operating systems to eliminate redundancy, create scale and enable synergies throughout Plant Leadership to the shop floor.

•    Develop and maintain Lean Six Sigma KPIs to monitor organizational health, complexity, and effectiveness and develop plans as appropriate as well as assessing resources.

•    Influence an environment that embraces Lean Six Sigma concepts and principles by building capability at the lowest levels of the organization.

•    Provide leadership to support the improvement of total delivered costs, reduced variability, reduced working capital, and improved supply chain effectiveness (supplier through customer) by implementing discipline and focus to processes.

•    Provide leadership to fully leverage standard practices to minimize waste and enable continuous improvement to drive improved business results.

•    Ensure a ready and able pool of talent exists to meet current and future continuous improvement needs and capabilities.

• Responsible for ensuring that processes and systems under their responsibility have procedures appropriate to the processes and comply both with the company's quality control requirements as well as with the Regulations of:
• ISO 13485
• GMP,
• CMDCAS,
• MDD,
• United States (21 CFR parts 820/210/211/11)
• European Community (MDD93 / 42 / EEC)
• Canada (Canadian Medical Device Regulations SOR / 98-282)
• Brazil (ANVISA resolution RDC No.16 2013, RDC 40 2015 (Class I, II), RDC 185 2001 Class III)
• Australia (Therapeutic goods act)
• Japan (MHLW MO 169)
• Mexico COFEPRIS (NOM-241-SSA1) and other applicable regulations.

Required Qualifications:

Education: Bachelor’s Degree preferrably in Engineering. The incumbent must have proven leadership skills, vision, and influence across teams over which the incumbent has no direct authority.

English: Advanced level.

Experience:

• Extensive and broad experience in various supply chain functions with demonstrated results using Lean Six Sigma Methodology.  Plant operations management is strongly desired.
• Close working relationships with Business Teams.
• Generally 10+ years experience in a continuous improvement role.
• Experience across multiple functions, and plant experience building Lean Manufacturing systems and experience with Six Sigma
• Sense of urgency, Communication, Leadership, Results-oriented, Teamwork, analytical, Disciplinary and Results-oriented.
• Six Sigma Green Belt or Black Belt strongly preferred, Experience building Lean Systems required.

Preferred Qualifications:

Skills:

• Willing to challenge the status quo and facilitate different perspectives to drive solutions
• Knowledge of medical device standards and regulatory requirements.
• Demonstrated positive energy to promote employee engagement and drive results
• Strong analytical and abstract thinking skills.

Ability to travel up to 20% of the time (domestic and international)