Senior Quality Engineersenior Quality Engineer

Experience

• 2-4 years (Preferably in medical device)

Education

• B. Tech / B.E

Key Responsibilities

• Complaint handling and Product investigations of medical devices.
• Review and analyze Literatures such as Clinical Reports, PMCF Reports etc. to identify Complaints.
• Investigations and root cause analysis of reported products in literature.
• Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
• Risk management –Risk assessment.
• Review of product and process documents for root cause analysis.

Skill Set

• Sound knowledge on complaint handling process of medical devices
• Knowledge of problem-solving methodology and root cause analysis
• Understanding of Risk Management process
• Strong Analytical ability
• Understanding of GDP, ISO 13485, EU MDR (Good to have).
• 7 QC tools, Problem Solving & CAPA.
• Ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
• Demonstrated organizational and written/verbal communication skills.
• Self-motivated and detailed oriented individual.
• Demonstrated ability to prioritize tasks in a deadline-driven environment.