Quality Engineer - Temp

About the role

CooperSurgical, a leading fertility and women’s healthcare company, is seeking a temporary Quality Engineer to support manufacturing changes, new product launches, and regulatory compliance. The role involves ensuring adherence to FDA regulations, ISO standards, and internal SOPs while driving process improvements.

Key responsibilities

• Ensure compliance with FDA regulations, ISO 13485, 21 CFR 820, customer requirements, and internal SOPs.
• Manage quality aspects of manufacturing changes, new product launches, and change orders.
• Perform process improvement recommendations and support validation activities (IQ, OQ, PQ).
• Investigate customer complaints, conduct root‑cause analysis, and implement corrective actions.
• Support internal and external audits and train personnel on specifications and inspection activities.

Required profile

• Bachelor’s degree in Engineering.
• 3+ years of experience in a Quality Engineering role within medical device manufacturing.
• Working knowledge of regulated environments (ISO 13485, 21 CFR 820).
• Experience with CAPA/NCR, process validation, and statistical data analysis.
• Strong written and oral communication skills in English and Spanish.

Required skills

• ISO 13485 and 21 CFR 820 compliance knowledge.
• CAPA/NCR root‑cause analysis.
• Process validation (IQ/OQ/PQ) and MSA.
• Statistical analysis of data.
• Microsoft Office proficiency.
• Blueprint reading and GD&T interpretation.
• Bilingual English/Spanish communication.