On-Site Quality Engineer: Lead CAPA & Process Improvement

Pretium Packaging, L.L.C.; East Manchester Township (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Pretium Packaging, a leading plastics packaging company, is seeking a hands-on Quality Engineer for our St. Louis MO facility to strengthen quality systems, standardize processes, validate materials and changes, and drive sustainable continuous improvement.

Approximately 70% of the role is on the production floor and 30% on documentation, analysis, and reporting; the candidate will lead CAPA, PFMEA, SPC, MSA, IQ/OQ/PQ activities and collaborate with Operations and Process Engineering to reduce

Qualifications

• Bachelor's degree in Quality, Manufacturing, Mechanical, Industrial, Plastics, or a related engineering discipline preferred.
• 5+ years of relevant experience in quality engineering, process engineering, manufacturing engineering, or technical quality in a manufacturing environment.
• Hands-on experience with root-cause analysis, CAPA, PFMEA, control plans, SPC, process capability analysis, and measurement systems analysis.

Responsibilities

• Lead structured problem-solving investigations using A3, 5 Why, fishbone analysis, data stratification, and hypothesis testing; verify root causes and corrective action effectiveness.
• Investigate customer complaints, nonconformances, recurring defects, and process failures; implement corrective and preventive actions (CAPA).
• Develop, maintain, and improve PFMEAs, risk assessments, control plans, inspection standards, and work instructions.
• Design and apply SPC strategies, including control charts, reaction plans, and process capability/performance measures (Cp, Cpk, Pp, and Ppk).
• Plan and perform MSA, including Gauge R&R, bias, linearity, stability, resolution, and attribute agreement studies as applicable.
• Support IQ/OQ/PQ validation through protocols, acceptance criteria, testing, deviation resolution, and documentation.
• Analyze manufacturing and quality data to identify variation and opportunities to reduce scrap, rework, complaints, and cost of poor quality.
• Conduct internal quality and process audits, address findings, and sustain improvements through standard work, training, and monitoring.
• Collaborate with Operations, Process Engineering, Maintenance, Tooling, Corporate Quality, suppliers, and plant-floor teams to improve process performance.
• Use Microsoft Excel and quality systems for analysis, reporting, documentation, and continuous improvement; follow plant safety and GMP expectations.

Skills

Root-cause analysis

CAPA

PFMEA

SPC

MSA

IQ/OQ/PQ

Data analysis

Excel

Cross-functional collaboration

On production floor

Education

Bachelor's degree in Quality/Manufacturing/Mechanical/Industrial/Plastics or related engineering

Tools

IQMS

Job description

Pretium Packaging, a leading plastics packaging company, is seeking a hands-on Quality Engineer for our St. Louis MO facility to strengthen quality systems, standardize processes, validate materials and changes, and drive sustainable continuous improvement.

Approximately 70% of the role is on the production floor and 30% on documentation, analysis, and reporting; the candidate will lead CAPA, PFMEA, SPC, MSA, IQ/OQ/PQ activities and collaborate with Operations and Process Engineering to reduce