Temporary Quality Engineer

About the role

CooperSurgical is seeking a Temporary Quality Engineer to support its medical device manufacturing operations. The role ensures compliance with FDA regulations, ISO standards, and internal SOPs while driving continuous improvement across product launches and process changes.

Key responsibilities

• Monitor and enforce compliance with FDA 21 CFR 820, ISO 13485, and customer specifications.
• Represent Quality on Change Orders and manage quality aspects of manufacturing changes and new product transfers.
• Identify and implement process improvements to enhance quality compliance.
• Participate in validation activities, including drafting and reviewing IQ, OQ, and PQ protocols and reports.
• Conduct root‑cause investigations for customer complaints and develop corrective action plans.
• Ensure proper disposition of non‑conforming materials and verify corrective actions prevent recurrence.
• Support internal and external audits and provide training to Quality and Manufacturing personnel.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 3 years of experience in a Quality Engineering role within medical device manufacturing.
• Familiarity with regulated environments (ISO 13485, 21 CFR 820).
• Proven experience with CAPA/NCR processes and root‑cause analysis.

Required skills

• ISO 13485
• 21 CFR 820
• CAPA and NCR management
• Process Validation (IQ, OQ, PQ)
• Measurement System Analysis (MSA)
• Statistical data analysis
• Root‑cause analysis