Quality Engineer II: Process & CAPA Leader

Endo; Raleigh (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Par Health in Raleigh, NC is seeking a Quality Engineer to interpret regulatory requirements and support cGMP manufacturing. You will apply statistical methods to identify root causes and drive continuous improvement across deviations, audits, CAPA, and supplier quality.

The ideal candidate has a B.S. in Chemical Engineering and 1–5 years in QA or pharma manufacturing, with knowledge of ICH Q7-10, FDA/EMA guidelines, and Six Sigma tools.

Qualifications

• BS degree in Chemical Engineering preferred; other degrees considered with relevant experience.
• 1-5 years' QA or pharmaceutical manufacturing experience.
• Knowledge of ICH guidelines (Q7-Q10), FDA, EMA, USP, EP, and JP.
• Experience in root cause analysis and risk analysis.
• Strong project management, problem solving, team building, and negotiation skills.

Responsibilities

• Provide QA support across Deviations, Supplier Quality, Product complaints, Audits, OOS, CAPA, and trend improvements.
• Apply statistical tools to analyze data, identify root causes, and develop corrective actions.
• Lead QA ownership for daily operations and monthly metrics.
• Support compliance efforts and benchmarking to implement best practices.
• Lead continuous improvement initiatives such as kaizen where applicable.
• Conduct risk analyses (FMEA) for changes to production or design processes.
• Assist supplier quality oversight and supplier corrective action plans.

Skills

Quality engineering

Regulatory knowledge

Statistical analysis

Communication skills

Problem solving

Education

B.S. Degree in Chemical Engineering

Tools

Excel

Minitab

Job description

Par Health in Raleigh, NC is seeking a Quality Engineer to interpret regulatory requirements and support cGMP manufacturing. You will apply statistical methods to identify root causes and drive continuous improvement across deviations, audits, CAPA, and supplier quality.

The ideal candidate has a B.S. in Chemical Engineering and 1–5 years in QA or pharma manufacturing, with knowledge of ICH Q7-10, FDA/EMA guidelines, and Six Sigma tools.