Operational Excellence Lead — Lean, CI & Cost Savings

Secant Group; Quakertown (Bucks County); On-site; USD 120,000 - 160,000; Full time

Job summary

Secant Group in Pennsylvania seeks a Site Operational Excellence Lead to drive Lean and continuous improvement across the facility. You will champion cost reduction, quality improvements, and production efficiency by mentoring teams and leading CI events.

The role requires a bachelor's in engineering or related field, experience in medical/biopharmaceutical sectors, and familiarity with ISO 13485, FDA guidelines, and ERP/eQMS systems. Excellent analytical and communication skills are essential.

Qualifications

• Bachelor's degree in engineering or related discipline, or equivalent combination of education and hands-on experience.
• Experience with medical or biopharmaceutical industry required.
• Strong analytical, organizational and communication skills.
• Experience with ISO 13485 and FDA guidelines.
• Six-sigma training a plus (Green Belt and/or Black Belt).
• Ability to effectively communicate with coworkers and management; business communication in English.

Responsibilities

• Identify and prioritize process improvements to meet Annual Objectives (AOs) and Break Through Objectives (BTOs).
• Lead and support a culture of Continuous Improvement across the site.
• Provide training and mentorship in Lean, 5S, VSM/PFMs, RCA and other CI tools.
• Analyze performance metrics and provide improvement recommendations.
• Develop and drive site action plans and establish Manufacturing Tier Meetings.
• Participate in global Operational Excellence and network meetings for standardization.
• Meet with key stakeholders to ensure proper resourcing, prioritization, and constraints.
• Establish Site KPIs with local leadership to communicate performance targets.

Skills

Lean

5S

VSM/PFMs

Root Cause Analysis

Six Sigma

ISO 13485

FDA guidelines

ERP system

eQMS

Education

Bachelor's degree in engineering or related discipline

Tools

ERP system

eQMS

Job description

Secant Group in Pennsylvania seeks a Site Operational Excellence Lead to drive Lean and continuous improvement across the facility. You will champion cost reduction, quality improvements, and production efficiency by mentoring teams and leading CI events.

The role requires a bachelor's in engineering or related field, experience in medical/biopharmaceutical sectors, and familiarity with ISO 13485, FDA guidelines, and ERP/eQMS systems. Excellent analytical and communication skills are essential.