Quality Engineer (CAPA & Cleanroom) in Duncan, SC 29334

About the role

We are seeking an experienced Quality Engineer to support day-to-day manufacturing operations within a cleanroom environment in Duncan, SC. This is a hands-on quality role for an engineer who can work closely with manufacturing teams, investigate quality issues, develop clear technical documentation, and drive corrective and preventive actions.

Key Responsibilities

• Support manufacturing teams as a Quality Engineer in daily production activities and quality management within a cleanroom environment.
• Work cross-functionally with Manufacturing, Engineering, Supplier Quality, Purchasing, and other teams to identify and resolve quality issues.
• Develop, implement, and maintain Standard Operating Procedures (SOPs), process flow charts, control plans, PFMEAs, and validation documentation.
• Manage internal and external non-conformances, CAPA, and complaint processes from investigation through closure.
• Lead or support root cause analysis and develop effective corrective and preventive action plans.
• Track CAPA effectiveness and verify that corrective actions prevent recurrence.
• Facilitate timely closure of quality investigations and corrective actions.
• Develop and analyze manufacturing quality trend charts to identify recurring issues and improvement opportunities.
• Recommend and implement continuous improvement initiatives based on quality and production trends.
• Support and participate in Kaizen events and Lean Manufacturing activities.
• Apply Lean Six Sigma problem-solving, risk assessment, and process control methodologies.
• Utilize quality and continuous improvement tools such as CDT&R, VOP, DRS, PSP, and FMEA to drive process improvements.
• Support Supplier Quality Engineering activities involving supplier-related quality issues and SCARs.
• Collaborate with Purchasing and Sourcing teams to evaluate supplier performance and support supplier selection and improvement activities.
• Prepare clear, accurate, and well-organized technical documentation, reports, analyses, and quality records.
• Ensure manufacturing processes and quality activities comply with applicable procedures and quality requirements.

Required Qualifications

• Bachelor's degree in an engineering discipline such as: Biomedical Engineering, Chemical Engineering, Pharmaceutical Engineering, Industrial Engineering, Systems Engineering, Quality Engineering, or Reliability Engineering, or equivalent relevant experience.
• Minimum 3 years of experience in manufacturing, quality engineering, or a related technical environment.
• Hands-on experience supporting manufacturing quality activities.
• Strong technical writing and documentation skills with the ability to clearly communicate technical information.
• Experience with quality processes including non-conformance, CAPA, complaints, and root cause analysis.
• Working knowledge of PFMEA, Process Control Plans, SOPs, process flow documentation, and validation.
• Understanding and practical application of Lean Six Sigma tools for problem solving, risk assessment, and process control.
• Strong analytical and problem-solving skills.
• Proficiency with Microsoft Office, including Excel, Word, Outlook, and Teams.
• Able to work effectively with cross-functional manufacturing teams.
• Able and willing to work in a cleanroom environment and complete required gowning procedures daily.

Preferred Qualifications

• Experience working in a medical device, pharmaceutical, biotechnology, or other regulated manufacturing environment.
• Experience with Supplier Corrective Action Requests (SCARs) and supplier quality improvement.
• Experience supporting supplier selection and performance management.
• Formal Lean Six Sigma training or certification.
• Experience facilitating Kaizen or continuous improvement events.
• Familiarity with quality trend analysis and manufacturing performance metrics.
• Experience with risk management and process validation.
• Knowledge of FMEA, corrective action effectiveness, and process control methodologies.