Quality Assurance Engineer - Operational Excellence Lead

QA Engineer II - Operational Excellence (PPI Lead)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. Drive Practical Process Improvement (PPI) culture and quality excellence across the Chakan site, delivering continuous improvement initiatives that enhance Safety, Quality, Delivery, Productivity, and Cost (SQDPC).

DESCRIPTION

How you will make an impact:

You will lead operational excellence and quality improvement initiatives that drive measurable business results. Through Lean principles, structured problem solving, and process optimization, you will support the site's annual PPI savings target of approximately $1M while ensuring Quality Management System compliance and sustainable performance.

What you will do:

• Lead deployment of Thermo Fisher's PPI culture and continuous improvement framework across the site
• Facilitate Kaizen events, Rapid Improvement Events (RIEs), Value Stream Mapping (VSM), Gemba walks, and Lean workshops to drive productivity and cost reduction
• Identify, prioritize, and execute improvement opportunities aligned with site and business objectives
• Lead Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and effectiveness verification to reduce non-conformances and quality issues
• Support Quality Management System (QMS) compliance and audit activities
• Monitor and analyze key performance metrics using dashboards and visual management tools to drive data-based decision-making
• Lead cross-functional improvement projects from identification through implementation and sustainment
• Coach and mentor employees on Lean, PPI, problem-solving, and continuous improvement methodologies
• Conduct training sessions on Lean tools, RCA, CAPA, and operational excellence practices
• Ensure all process improvement activities comply with industry standards and regulatory requirements

REQUIREMENTS

How you will get here:

• Bachelor's degree in Engineering, Manufacturing, Operations Management, Process Engineering or related field
• 5–8 years of experience in Operations Excellence, Continuous Improvement, Lean Manufacturing, or Industrial Engineering
• Certified Lean Six Sigma Green Belt or Black Belt (or equivalent certification)
• Proven track record of leading successful process improvement projects
• Strong analytical, problem-solving, and project management skills
• Excellent verbal and written communication skills and interpersonal skills with ability to work collaboratively across functions
• Excellent documentation and technical writing skills for developing SOPs, protocols and reports
• Ability to work independently while contributing effectively in team environments
• Proficiency in data analysis tools and software
• Knowledge of ISO 9001 (Quality Management Systems) and ISO 45001 (Occupational Health and Safety Management Systems)
• Experience in project business sector preferred
• Knowledge of ERP systems and MES preferred

Experience Level

Mid Level