Quality Engineer
Published date: 2024/01/10
- Location: haryana, gurugram, India
Responsibilities:
• Able to investigate complaints from field and literatures, and able to find root-cause.
• Review and analyze literatures such as Clinical Reports, PMCF Reports etc. to identify complaints.
• Ability to read and understand production records (DHR’s) engineering drawings, test certificates,
risk assessments etc.
• Able to support Non-conformance (NC) and CAPA process.
• Collaborate with engineers and technicians on projects.
• Ability to work effectively with various work groups to assure conformance to regulatory requirements, internal process, and policies.
• Ensure compliance with safety and quality standards.
Skillset:
• Sound knowledge of complaint handling process of medical device.
• Knowledge of problem-solving methodology and root-cause analysis.
• Understanding of Risk Management Process.
• Understanding of 7 QC tools, Problem Solving, and CAPA.
• Demonstrate organizational and written/verbal communication skills.
• Strong Analytical Ability.
• Self-motivated and detailed oriented individual.
• Good to have GDP, ISO 13485, and EUMDR knowledge.
Preferred:
• Degree in Mechanical, Biotechnology, or Biomedical Engineering.
• Bachelors with at least 2 years of experience in medical device industry.
• Strong understanding of manufacturing processes and safety regulations
• Able to investigate complaints from field and literatures, and able to find root-cause.
• Review and analyze literatures such as Clinical Reports, PMCF Reports etc. to identify complaints.
• Ability to read and understand production records (DHR’s) engineering drawings, test certificates,
risk assessments etc.
• Able to support Non-conformance (NC) and CAPA process.
• Collaborate with engineers and technicians on projects.
• Ability to work effectively with various work groups to assure conformance to regulatory requirements, internal process, and policies.
• Ensure compliance with safety and quality standards.
Skillset:
• Sound knowledge of complaint handling process of medical device.
• Knowledge of problem-solving methodology and root-cause analysis.
• Understanding of Risk Management Process.
• Understanding of 7 QC tools, Problem Solving, and CAPA.
• Demonstrate organizational and written/verbal communication skills.
• Strong Analytical Ability.
• Self-motivated and detailed oriented individual.
• Good to have GDP, ISO 13485, and EUMDR knowledge.
Preferred:
• Degree in Mechanical, Biotechnology, or Biomedical Engineering.
• Bachelors with at least 2 years of experience in medical device industry.
• Strong understanding of manufacturing processes and safety regulations
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