Quality Engineer

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

• Pay or shift range: $90,000 USD to $120,000 USD
  The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Description

Quality Engineer
Pretium Packaging | St, Louis MO
Job Type: Full-time | Work Setting: On-site
Shift: Day shift, Monday–Friday (7:00 AM–4:00 PM or 8:00 AM–5:00 PM)
Pay Range: $90,000–$120,000 annually
Reports To: Plant Quality Manager

Grow Boldly with Pretium:

Are you a hands-on Quality Engineer who enjoys solving manufacturing problems, improving processes, and partnering with production teams?

Pretium Packaging is seeking a Quality Engineer for our St. Louis MO facility. This role strengthens quality systems, standardizes processes, validates materials and manufacturing changes, and drives sustainable continuous improvement. Approximately 70% of the position is spent on the production floor and 30% on documentation, analysis, and reporting.

Who We Are:

Pretium Packaging, founded in 1992, is a leading supplier of injection‑blow molded plastic containers, known for its commitment to quality, value, and customer service. With manufacturing facilities across North America, we provide packaging solutions to brand owners in the United States and Canada.

What You’ll Do:

• 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 Process Failure Mode and Effects Analyses (PFMEAs), risk assessments, control plans, inspection standards, and work instructions.
• Design and apply Statistical Process Control (SPC) strategies, including control charts, reaction plans, and process capability/performance measures (Cp, Cpk, Pp, and Ppk).
• Plan and perform Measurement System Analysis (MSA), including Gauge R&R, bias, linearity, stability, resolution, and attribute agreement studies as applicable.
• Support material, tooling, mold, machine, equipment, and process validation through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), including 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.

What You’ll Bring:

• Bachelor’s degree in Quality, Manufacturing, Mechanical, Industrial, Plastics, or a related engineering discipline preferred.
• Minimum of 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.
• Experience performing Gauge R&R studies and interpreting capability and performance metrics (Cp, Cpk, Pp, Ppk).
• Working knowledge of IQ/OQ/PQ validation, risk‑based sampling, test methods, acceptance criteria, and technical documentation.
• Strong analytical, communication, cross‑functional collaboration, and problem‑solving skills; proficiency in Microsoft Excel.
• Comfort spending significant time on the production floor, working with operators and leadership.
• Plastics, rigid packaging, food‑contact packaging, pharmaceutical packaging, or regulated manufacturing experience preferred.
• ISO 9001, Lean/Six Sigma, ASQ Certified Quality Engineer (CQE), Green Belt/Black Belt, and IQMS familiarity are pluses.

Why Join Pretium?

Make a measurable impact by solving manufacturing problems at the source, strengthening process reliability, and partnering across teams to deliver high-quality packaging.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.