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

Title - Quality Engineer

Department Quality & Regulatory Affairs



Job Location Type In Person



Location Duncan, SC 29334



Job Type 6-Month Contract



Work Schedule 100% Onsite | Standard Manufacturing Schedule

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.

The ideal candidate combines practical manufacturing quality experience with strong technical writing, root cause analysis, CAPA, FMEA, Lean Six Sigma, and process control skills. Candidates must be comfortable completing full cleanroom gowning requirements and working directly with cross-functional teams to resolve production issues.

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
  • Mechanical Engineering
  • Systems Engineering
  • Quality Engineering
  • 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 .
• Ability to work effectively with cross-functional manufacturing teams.
• Ability and willingness 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.

Top Skills

• Technical Writing & Documentation
• Manufacturing Quality
• CAPA
• Root Cause Analysis
• Non-Conformance Management
• PFMEA / FMEA
• Process Control Plans
• Lean Six Sigma
• Continuous Improvement / Kaizen
• Quality Trend Analysis
• Supplier Quality / SCAR
• Process Validation
• SOP Development
• Microsoft Excel & Word
• Cleanroom Manufacturing