Lead Quality Engineer

Location: Pennsylvania

Job Description: Lead CAPA investigations, RCA, corrective/preventive actions, effectiveness checks, and closure. Perform Root Cause Analysis using 5 Whys, Fishbone, Fault Tree Analysis, and other methodologies. Lead process validation/revalidation, including IQ/OQ/PQ and validation protocols/reports. Perform risk assessments, FMEA/PFMEA, and quality issue investigations. Investigate NCRs, nonconformances, deviations, complaints, and manufacturing quality issues. Support change control, process improvements, defect reduction, and quality data analysis. Support internal, customer, and regulatory audits. Ensure compliance with FDA, ISO 13485, GMP, and medical device quality systems. Provide technical guidance to junior engineers and cross-functional teams.

Required Qualifications: Bachelor's degree in Engineering, Quality, Manufacturing, or related field.5–10 years of Quality Engineering experience, preferably 8+ years in medical device manufacturing. Strong experience with CAPA, RCA, IQ/OQ/PQ, Risk Management, FMEA/PFMEA, and NCR investigations. Strong knowledge of FDA, ISO 13485, GMP, and regulated medical device manufacturing. Strong analytical, problem-solving, documentation, and communication skills.