Quality Systems Engineer — Investigation & CAPA Leader

Contract Pharmacal Corp; Hauppauge (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

Contract Pharmacal Corp in Hauppauge, NY, is looking for a Quality Systems Engineer to enhance quality system activities. Your primary responsibilities will include leading quality event investigations and implementing corrective actions.

The ideal candidate will possess a Bachelor's degree in a related field and at least 5 years of experience in Quality Assurance or Quality Engineering within a regulated environment. Strong technical writing and analytical skills are essential.

We offer a full-time position with a competitive salary range of $80,000 to $110,000 per year based on experience.

Qualifications

• 5 or more years of experience in Quality Assurance or Quality Engineering in regulated environments.
• Certifications in Six Sigma, Root Cause Analysis, cGMP are preferred.
• Experience in leading quality event investigations and CAPAs.

Responsibilities

• Lead quality event investigations and ensure documentation meets regulatory standards.
• Drive development of risk-based CAPAs.
• Support inspection readiness and audits.

Skills

Technical writing skills

Data analysis proficiency

Root cause analysis

Knowledge of cGMPs and FDA regulations

Risk-based decision-making

Education

Bachelor’s degree in relevant field

Tools

Minitab

Microsoft Office Suite

Job description

Contract Pharmacal Corp in Hauppauge, NY, is looking for a Quality Systems Engineer to enhance quality system activities. Your primary responsibilities will include leading quality event investigations and implementing corrective actions.

The ideal candidate will possess a Bachelor's degree in a related field and at least 5 years of experience in Quality Assurance or Quality Engineering within a regulated environment. Strong technical writing and analytical skills are essential.

We offer a full-time position with a competitive salary range of $80,000 to $110,000 per year based on experience.