Quality Engineer — On‑Site, Data‑Driven Problem Solver

PRETIUM; Manchester (York County); On-site; USD 90,000 - 120,000; Full time

Job summary

Pretium Packaging in St. Louis, MO is seeking a hands-on Quality Engineer to strengthen quality systems, standardize processes, validate materials, and drive continuous improvement on the production floor and in documentation.

The role emphasizes root-cause analysis, CAPA, PFMEA, SPC, MSA, and IQ/OQ/PQ validation, with a strong collaboration focus across operations and engineering teams. Day shifts, on-site.

Qualifications

• Bachelor’s degree in Quality, Manufacturing, Mechanical, Industrial, Plastics, or related engineering preferred.
• Minimum of 5 years of relevant experience in quality engineering, process/manufacturing engineering, or technical quality.
• Hands-on experience with root-cause analysis, CAPA, PFMEA, control plans, SPC, and MSA.
• Experience performing Gauge R&R studies and interpreting Cp/Cpk/Pp/Ppk metrics.

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 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, Ppk).
• Plan and perform MSA, including Gauge R&R, bias, linearity, stability, resolution, and attribute agreement studies.
• Support IQ/OQ/PQ validation, including protocols, acceptance criteria, testing, deviation resolution, and documentation.
• Analyze manufacturing data to identify variation and opportunities to reduce scrap and cost of quality.
• Conduct internal quality and process audits, address findings, and sustain improvements through standard work and training.
• Collaborate with Operations, Process Engineering, Maintenance, Tooling, and suppliers to improve process performance.
• Use Excel and quality systems for analysis, reporting, and GMP adherence.

Skills

Root-cause analysis

CAPA

PFMEA

SPC

MSA

IQ/OQ/PQ validation

Excel proficiency

Cross-functional collaboration

Data analysis

Education

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

Tools

IQMS familiarity

Gauge R&R tools

Job description

Pretium Packaging in St. Louis, MO is seeking a hands-on Quality Engineer to strengthen quality systems, standardize processes, validate materials, and drive continuous improvement on the production floor and in documentation.

The role emphasizes root-cause analysis, CAPA, PFMEA, SPC, MSA, and IQ/OQ/PQ validation, with a strong collaboration focus across operations and engineering teams. Day shifts, on-site.