Quality Engineer

Quality Engineer

The Quality Engineer supports manufacturing and new product development by leading validation activities, driving root cause analysis, and implementing robust quality systems. This role develops and maintains validation documentation and SOPs, provides statistical analysis and reporting, and partners with internal teams and customers to ensure processes, equipment, and products consistently meet defined quality standards. The Quality Engineer also plays a key role in continuous improvement initiatives and in building quality capability across the organization through training and coaching.

• Facilitate and maintain comprehensive validation project documentation for equipment, processes, and related systems.
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation, facilities, software, and manufacturing processes.
• Collaborate with customers on equipment and process validation activities to ensure alignment with their requirements and quality standards.
• Serve as the database administrator for InfinityQS Statistical Process Control (SPC) software, ensuring data integrity and effective system use.
• Provide statistical analysis support for manufacturing operations, new product development projects, trials, and validation activities.
• Conduct quality and engineering studies to support manufacturing operations and improve process capability and product quality.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) related to validation and risk management.
• Monitor, analyze, and prepare Key Performance Indicators (KPIs) for major customers, providing clear insight into quality and process performance.
• Lead Corrective Action and Preventative Action (CAPA) activities, including facilitating root cause investigations and implementing effective corrective measures.
• Apply sound investigation and problem-solving techniques to resolve quality and process issues within the manufacturing plant.
• Train and coach associates on quality topics such as Statistical Process Control (SPC) and CAPA methodologies to build quality awareness and competency.
• Drive continuous improvement initiatives with internal teams and external partners to enhance product quality, process efficiency, and customer satisfaction.

• Proven experience in quality engineering within a manufacturing environment.
• Hands-on experience with validation activities, including the development and execution of IQ, OQ, and PQ protocols.
• Strong knowledge of process validation principles and practices.
• Demonstrated ability to perform root cause analysis and apply structured problem-solving methods.
• Proficiency with Statistical Process Control (SPC) tools and techniques.
• Experience administering or working extensively with InfinityQS or similar SPC software platforms.
• Ability to develop and maintain SOPs related to validation and risk management.
• Strong analytical skills with the ability to perform statistical analysis to support manufacturing, NPD, trials, and validations.
• Experience leading or facilitating CAPA activities from issue identification through to effective closure.
• Effective communication and training skills, with the ability to explain quality concepts such as SPC and CAPA to associates at various levels.

• Validation of equipment, sanitation, facilities, software, and processes.
• Experience collaborating directly with customers on validation projects and quality initiatives.
• Familiarity with monitoring and reporting Key Performance Indicators (KPIs) for major customers.
• Demonstrated ability to work cross-functionally with internal teams and external partners on continuous improvement initiatives.
• Strong documentation skills, with attention to detail in validation records, SOPs, and quality reports.
• Comfort working in a data-driven environment and using statistical insights to inform decisions and improvements.

The role operates in a manufacturing-focused environment that combines time on the production floor with office-based analytical and documentation work. You will regularly interact with production, engineering, and quality teams, as…