Senior Quality Engineer (Biotech)

Location: US - Greenwood, South Carolina

Company

hirify.global manufactures medicines across a globally connected network of more than 30 sites on five continents.

What you will do

• Lead customer complaint investigations, root cause analyses, and corrective action processes.
• Analyze customer feedback, quality system failures, process data, and Voice of the Customer trends to develop improvement plans.
• Establish and maintain quality specifications, controls, and monitoring processes supporting product quality and regulatory compliance.
• Lead customer GMP and Quality System audits, including audit readiness and corrective action verification.
• Provide quality leadership for manufacturing product and process issues, including risk assessment, escalation, and resolution recommendations.
• Analyze quality metrics, complaint trends, process capability data, and other performance indicators to support continuous improvement.

Requirements

• Bachelor’s degree in Business, Engineering, Science, or another technical discipline, or equivalent education and experience.
• 5–10 years of experience in manufacturing, quality engineering, quality assurance, or a related technical environment.
• Experience with root cause analysis, corrective action management, and continuous improvement initiatives.
• Experience using 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, with proficiency in Microsoft Word and Excel and a passing score on the Munsell Color Vision Test.

Nice to have

• Six Sigma certification.
• Experience with Minitab or similar statistical analysis software.
• Experience with SAP, customer-facing manufacturing work, quality system audits, or GMP compliance activities.

Culture & Benefits

• Collaboration, accountability, excellence, passion, and integrity are core values.
• Work with teams supporting the manufacture of medicines and the development of life-science therapies.
• Equal employment opportunities are offered to qualified applicants.