Quality Engineer II - cGMP Process & Continuous Improvement

Endo; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Mallinckrodt is seeking a Quality Engineer in Raleigh, NC to provide Process and Quality Engineering support in a cGMP manufacturing setting, ensuring the highest quality product for customers. The role emphasizes statistical analysis, data trending, and continuous improvement across QA activities.

Responsibilities include deviations, supplier quality, product complaints, internal audits, OOS, CAPA, change control, and risk analysis.

Qualifications

• B.S. in Chemical Engineering or related field preferred.
• 1–5 years QA or pharmaceutical manufacturing experience.
• Knowledge of ICH Q7, Q8, Q9, Q10 and FDA/EMA/USP/EP/JP guidelines.
• Strong problem solving, project management and communication skills.
• Experience with Six Sigma tools.

Responsibilities

• Interpret and apply cGMP quality systems in manufacturing.
• Lead quality system ownership and daily QA activities.
• Analyze data with statistical tools to identify root causes.
• Lead CAPA and RCA activities.
• Support supplier quality and audits.
• Participate in risk analyses (FMEA) for changes.

Skills

Project management

Problem solving

Team building

Negotiation

Education

B.S. in Chemical Engineering

Tools

Excel

Minitab

Statistical software

Job description

Mallinckrodt is seeking a Quality Engineer in Raleigh, NC to provide Process and Quality Engineering support in a cGMP manufacturing setting, ensuring the highest quality product for customers. The role emphasizes statistical analysis, data trending, and continuous improvement across QA activities.

Responsibilities include deviations, supplier quality, product complaints, internal audits, OOS, CAPA, change control, and risk analysis.