Title:  Quality Transformation Lead

Job Summary

The Quality Transformation Lead will lead transformative global efficiency programs.  This position will evaluate process capability within quality, identify waste/redundancy, create business cases to change, and lead the development/deployment of the improvement.  Individuals in this position will be change agents that influence enterprise operating models and standards.

Essential Duties and Responsibilities

• Development of current-state process maps, problem definition, and measurable improvements.
• Conduct stakeholder analysis and formulate communication plans to create a shared need.
• Assemble a tangible business case and seek funding through standard review process.
• Develop and maintain a multi-phased project and resource plan.
• Present program status updates to executive champions.
• Lead a cross-functional process design including risk mitigation, KPI’s, user requirements/user acceptance criteria, and standard work.
• Integrate process into existing QMS standards.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Measure project plans, budget, and resource allocation to deliver solution as expected.
• Create and release training that supports the solution.
• Establish a support network and governance structure to implement and maintain the solution.
• Identify and coordinate with related process changes across the organization to maintain standard enterprise solutions.
• Execute seamless hand-offs of newly designed process with global process owners and supporting teams.
• All other duties as required.

Additional Responsibilities

• Works independently with minimal guidance.
• Develops technical knowledge, requires working knowledge and experience in project management.
• Manages single workstreams locally/globally and may work across multiple workstreams.
• Maintain clear communication paths with stakeholders.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

Education

• Bachelor's Degree Science related field, Chemistry, Biology, engineering required or equivalent experience 

Work Experience

• Minimum 5 years' in Contrinuous Improvement / Operational Excellence.
• Minimum of 5 years’ experience in pharmaceutical or medical device environment; minimum 2 years’ experience in a Quality role.

Preferred Knowledge, Skills and Abilities

• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2015, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP, MDR.
• Work independently and in a team environment.  Experience navigating matrix/global organizations.
• Demonstrated enterprise-level deployment experience.
• Ability to convey innovativeness in a clear/structured way when proposing alternate solutions for process improvement.
• Leverage data to identify root cause and to measure improvements.
• Experience with SAP, data analytics dashboards, data governance, process automation, and Digital QMS is preferred.

License and Certifications

• Lean Six Sigma Green Belt or Black Belt certification preferred.
• PMP certification preferred.
• ASQ CQE certification desirable.

Travel Requirements

Physical Requirements