Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
3+ years of Quality Engineering, Quality Assurance, or Manufacturing Quality experience in a regulated industry.
At least 3 years of hands-on experience conducting investigations for nonconformances (NCs), deviations, and quality events.
Demonstrated experience leading nonconformance, deviation, CAPA, and root cause investigations in a manufacturing setting.
Experience supporting manufacturing operations within a high-volume production environment.
Strong understanding of FDA-regulated quality systems, compliance requirements, and applicable standards.
Proven ability to manage multiple investigations and priorities simultaneously in a fast-paced environment.
Experience reviewing and approving quality documentation, including protocols, reports, and procedures.
Strong analytical and problem-solving skills, including the ability to interpret data and identify trends.
Solid technical writing skills for clear, concise, and compliant documentation of investigations, CAPAs, and risk assessments.
Experience with nonconformance reports (NCR/NCMR) and quality control processes.
Hands-on experience performing root cause analysis using structured tools and methodologies.
Ability to collaborate effectively with cross-functional manufacturing teams and provide clear quality guidance.
Experience with validation activities, including IQ, OQ, and PQ protocol review and approval.