Quality Systems & Process Improvement Engineer

Par Health; North Carolina; On-site; USD 70,000 - 90,000; Full time

Job summary

Par Health is seeking a Quality Engineer to interpret and apply cGMP regulations and Quality Systems in a manufacturing environment. The role provides Process / Quality Engineering support to ensure delivery of the highest quality product and applies statistical tools for continuous improvement.

The position covers deviations, supplier quality, product complaints, audits, OOS, CAPA, validation, and change control, with emphasis on root-cause analysis and corrective actions in a collaborative

Qualifications

• B.S. in Chemical Engineering preferred; other relevant degrees considered with experience.
• 1-5 years’ experience in QA or pharmaceutical manufacturing.
• Knowledge of ICH Q7–Q10, FDA, EMA, USP, EP, and JP guidelines.
• Experience with root cause analysis and risk analysis.
• Strong project management, problem solving, and communication skills.
• Ability to work cross-functionally and drive continuous improvement.

Responsibilities

• Interpret and apply regulatory requirements and quality systems in a cGMP environment.
• Provide process/quality engineering support across the facility to ensure product quality.
• Lead or participate in deviations, CAPA, change control, validation, and annual product review.
• Utilize statistical tools to analyze data, identify root causes, and develop corrective actions.
• Support internal audits, supplier quality, and quality system improvements.
• Contribute to risk analyses (FMEA) and process mapping to reduce defect risk.
• Collaborate with production teams and extended core QA teams as needed.

Skills

Quality Systems

Data analysis

Root cause

CAPA

FMEA

Change Control

Validation

Kaizen

5S

Audits

Excel

Minitab

Education

B.S. in Chemical Engineering

Tools

Excel

Minitab

Job description

Par Health is seeking a Quality Engineer to interpret and apply cGMP regulations and Quality Systems in a manufacturing environment. The role provides Process / Quality Engineering support to ensure delivery of the highest quality product and applies statistical tools for continuous improvement.

The position covers deviations, supplier quality, product complaints, audits, OOS, CAPA, validation, and change control, with emphasis on root-cause analysis and corrective actions in a collaborative