Senior Quality Engineer

Posted 2 Days Ago
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Greenwood, SC, USA
In-Office
Senior level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
Lead customer complaint investigations, root cause analyses, corrective actions, quality audits, and GMP compliance initiatives. Analyze quality metrics, customer feedback, process capability, and VOC trends to drive continuous improvement. Establish quality controls, support manufacturing issue resolution, assess quality-system risks, and communicate recommendations to customers and cross-functional teams. The role requires strong quality engineering expertise, statistical improvement methods, customer engagement, and regulatory compliance experience in a manufacturing environment.
Summary Generated by Built In

 

As a Senior Quality Engineer, you will play a critical role in driving customer satisfaction, product quality, and continuous improvement across our manufacturing operations. Working closely with customers and cross-functional teams, you will lead quality investigations, support compliance initiatives, and leverage Voice of the Customer (VOC) insights to enhance products, processes, and the overall customer experience. In this highly visible role, you will serve as a trusted quality partner, helping to ensure regulatory compliance, resolve complex quality issues, and drive sustainable improvements that support both business objectives and customer expectations.

What Will You Do 

  • Lead customer complaint investigations, root cause analyses, and corrective action processes, ensuring timely resolution and effective communication with customers and internal stakeholders. 

  • Drive customer experience improvement through analysis of customer feedback, quality system failures, process performance data, and Voice of the Customer (VOC) trends, translating findings into actionable improvement plans. 

  • Establish and maintain quality specifications, controls, and monitoring processes to support product quality, regulatory compliance, and customer satisfaction. 

  • Lead customer GMP and Quality System audits, ensuring audit readiness, successful execution, and timely implementation and verification of corrective actions. 

  • Provide quality leadership and technical support for product and process issues identified during manufacturing operations, including risk assessment, issue escalation, and resolution recommendations. 

  • Analyze and communicate quality metrics, customer complaint trends, process capability data, and other key performance indicators to drive data-based decision making and continuous improvement across the organization. 

  • Conduct risk-based assessments and audits of quality systems to identify improvement opportunities, strengthen compliance, and enhance overall system effectiveness. 

  • Support commercial and operational excellence initiatives through direct customer engagement, quality consultation, continuous improvement activities, and implementation of quality goals that support business and customer requirements. 

What are we looking for

  • Bachelor's degree in Business, Engineering, Science, or another technical discipline OR equivalent degree/experience.

  • 5-10 years of experience in manufacturing, quality engineering, quality assurance, or a related technical environment. 

  • Proven experience conducting root cause analysis, managing corrective actions, and driving continuous improvement initiatives. 

  • Demonstrated experience utilizing Six Sigma methodologies and quality improvement tools; Six Sigma certification preferred. 

  • Strong verbal and written communication skills with the ability to effectively engage customers and cross-functional teams. 

  • Ability to work independently in a fast-paced manufacturing environment. 

  • Proficiency with Microsoft Office applications, including Word and Excel. 

  • Passing score on the Munsell Color Vision Test. 

Would be great if you had this:

  • Experience with Minitab or similar statistical analysis software. 

  • Experience with SAP. 

  • Experience working directly with customers in a manufacturing or regulated industry environment. 

  • Experience auditing quality systems and supporting GMP compliance activities. 

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Skills Required

  • Bachelor's degree in Business, Engineering, Science, another technical discipline, or equivalent degree/experience
  • 5-10 years of experience in manufacturing, quality engineering, quality assurance, or a related technical environment
  • Experience conducting root cause analysis, managing corrective actions, and driving continuous improvement initiatives
  • Experience utilizing Six Sigma methodologies and quality improvement tools
  • Strong verbal and written communication skills for engaging customers and cross-functional teams
  • Ability to work independently in a fast-paced manufacturing environment
  • Proficiency with Microsoft Office applications, including Word and Excel
  • Passing score on the Munsell Color Vision Test
  • Six Sigma certification
  • Experience with Minitab or similar statistical analysis software
  • Experience with SAP
  • Direct customer experience in a manufacturing or regulated industry environment
  • Experience auditing quality systems and supporting GMP compliance activities
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The Company
HQ: Basel
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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