Senior Quality Engineer

Role: Senior Quality Engineer supporting manufacturing, engineering, operations, supply chain, and customer quality activities at a biopharma manufacturing site. Responsibilities: lead investigations, root cause analysis, FMEA, validation, change management, supplier quality, CAPA, and customer complaint resolution; ensure compliance with ISO 9001, GMP, and FDA 21 CFR 820; support audits and regulatory inspections; develop and review quality documentation; monitor calibration, perform testing, and participate in process improvements. Qualifications: Bachelor's in Engineering or Life Science; 7+ years in Quality or Manufacturing Engineering; strong knowledge of ISO 9001 and FDA 21 CFR 820; expertise in CAPA, root cause analysis, problem solving, and statistical data analysis; excellent communication skills. Preferred: ASQ CQE, CQA, Lead Auditor certifications; experience with eQMS platforms like MasterControl; background in biologics, biologic manufacturing, or medical devices. HighValue: biopharma manufacturing, GMP compliance, quality investigations, validation, supplier quality, audits, biologics or medical devices, process validation. WorkSetup: onsite with occasional travel.