Continuous Improvement Lead

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

The Site Operational Excellence Lead identifies, plans, and executes performance improvement activities across the facility and in alignment with organizational strategic goals and objectives. Through the implementation of lean methodology and other best practices, you will champion a culture of continuous improvement by empowering others to seek better ways of working. This role will work closely with Site leadership team members to enhance production capabilities, improve quality, reduce costs, and achieve customer service goals.

What you will do:

• Identifies and prioritizes business process improvements and critical initiatives required to achieve both short-term and longer-term organizational goals - Annual Objectives (AOs) and Break Through Objectives (BTOs).
• Leads and supports a culture of Continuous Improvement across the site and provide training and mentorship as needed in support of Operational Excellence initiatives.
• Provides and implements a Site Continuous Improvement program in coordination with global organizational support, inclusive of training and execution around Lean, 5S, VSM/PFMs, Root Cause Analysis, and other "best practices" CI tools and methodologies.
• Analyzes existing operational performance metrics such as run-rates, waste, capacity, and yields and provide recommendations for improvement opportunities.
• Develops and drives Site action plans pertaining to performance improvements and establishes Manufacturing Tier Meetings with Site leadership team members.
• Participate in global Operational Excellence and network team meetings to collaborate and ensure standardization of best practices and alignment on organizational activities.
• Meets with key stakeholders as required to ensure proper resourcing alignment, prioritization, constraints identification, etc. on departmental activities.
• Establishes Site Key Performance Indicators (KPIs) with local leadership to ensure performance targets are communicated and transparent throughout the facility.
• Identifies top opportunities for Cost Savings and helps prioritize best allocation of resources to execute and realize these savings for leadership review.
• Leads Continuous Improvement events such as Kaizens, Tiger Teams, and/or CI Projects as necessary to elevate business productivity and provide team members with structured support and tools to resolve issues/opportunities.
• Conducts operational reviews and audits.
• Identifies staffing requirements, participates in selection and hiring process, interviews applicants, and makes hire recommendations.

Who you are:

• Minimum bachelor's degree in engineering or a related discipline, or equivalent combination of education and hands-on experience.
• Experience with medical or bio pharmaceutical industry required.
• Strong analytical, organizational and communication skills.
• Both independent self-starting work habits and as a cross-functional team member.
• Results Oriented: Being persistent and showing perseverance in achieving concrete and tangible results out of personal responsibility; getting optimum results from situations and being ready to act and show drive in case of obstacles or resistance.
• 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 is conducted in English.
• Familiarity with an ERP system and Quality Management System (eQMS) preferred.

About Us:

Secant Group, part of the Solesis family of companies, develops custom next-generation solutions that help innovators turn bold ideas into lasting breakthroughs. With more than 80 years of materials expertise, Secant supports the medical device, pharmaceutical, and aerospace industries through advanced materials, medical textiles, and bioresorbable technologies. Operating in Pennsylvania, USA, Secant Group employs more than 250 employees across three facilities in Perkasie, Quakertown, and Telford.

Guided by a commitment to innovation, quality, and customer success, Secant partners with customers to solve complex challenges and accelerate the development of next-generation technologies. Employees play a vital role in advancing solutions that improve lives and help shape the future of healthcare and other high-performance industries.