Quality Engineer

A growing advanced manufacturing organization is seeking a Quality Engineer to support and enhance quality systems, process excellence, customer satisfaction, and continuous improvement initiatives within a highly regulated manufacturing environment.

This role will work closely with Production, Engineering, Supply Chain, R&D, and customers to ensure compliance with quality standards, drive corrective actions, support audits, and improve overall process performance.

• Support and maintain the Quality Management System (QMS).
• Ensure compliance with ISO 9001, ISO 14001, customer, and regulatory requirements.
• Participate in internal, customer, certification, and regulatory audits.
• Maintain documentation control, record retention, and product traceability programs.
• Support batch review and release activities to ensure compliance with specifications and customer requirements.

• Monitor process performance and product quality metrics.
• Develop inspection methods, control plans, testing protocols, and acceptance criteria.
• Support process validation, cleaning validation, and quality assurance initiatives.
• Analyze quality data to identify trends and improvement opportunities.
• Partner with cross-functional teams to reduce variation and improve manufacturing performance.
• Lead investigations involving non-conformances, deviations, customer complaints, and quality incidents.
• Utilize structured problem-solving tools such as:
• 8D
• Fishbone Diagrams
• 5 Whys
• Develop, implement, and verify corrective and preventive actions (CAPA).
• Track recurring issues and implement sustainable corrective measures.
• Support customer audits and respond to quality-related inquiries.
• Review supplier quality documentation and support supplier corrective action activities.
• Collaborate with suppliers to improve quality performance and compliance.

• Bachelor's Degree in Engineering, Chemistry, Quality, Manufacturing, or a related technical discipline.
• Minimum 3+ years of Quality Engineering experience within a manufacturing environment.
• Experience supporting ISO 9001 or comparable quality management systems.
• Hands-on experience with CAPA, non-conformance investigations, and root cause analysis.
• Experience creating technical reports, quality documentation, and customer-facing quality communications.
• Strong analytical, communication, and problem-solving skills.
• Experience utilizing statistical analysis software such as Minitab, JMP, or similar.
• knowledge of SPC, process monitoring, and manufacturing quality metrics.

• ASQ Certified Quality Engineer (CQE) or willingness to obtain certification.
• Experience in chemical manufacturing, specialty chemicals, advanced materials, semiconductor supply chains, or other highly regulated manufacturing environments.
• Experience with audit preparation and supplier quality management.
• Familiarity with quality management software platforms.
• Lean Manufacturing, Six Sigma, or Continuous Improvement experience.
• Master's degree in Engineering, Chemistry, or a related field.

• High-visibility quality role with significant cross-functional exposure.
• Opportunity to influence quality systems, customer satisfaction, and operational performance.
• Work within a regulated manufacturing environment focused on quality excellence.
• Strong career growth potential and advancement opportunities.
• Collaborative culture with a focus on continuous improvement and operational excellence.