Senior Quality Engineer - Medical Device CSV & Compliance

Tempus, Inc.; New York (NY); On-site; USD 100,000 - 150,000; Full time

Job summary

Tempus, Inc. is seeking a Senior Quality Engineer to lead verification and validation of systems supporting Tempus Medical Devices. This role involves ensuring regulatory compliance, developing CSV policies, and collaborating with cross-functional teams. Candidates should have 5+ years in FDA regulated domains and expertise in Computer System Validation. The position is based in New York City, with a competitive pay range of $100,000-$150,000 and a full range of benefits.

Qualifications

• 5+ years experience in FDA regulated domain like medical device or pharma.
• 3+ years experience in Computer System Validation (CSV).
• Knowledge of FDA Quality System Regulations and ISO 13485.

Responsibilities

• Lead verification, validation and maintenance of host systems.
• Develop and maintain CSV policies and procedures.
• Support regulatory compliance of host systems.

Skills

Risk Assessment

Computer System Validation

Quality Systems Practices

Collaboration

Education

BA/B.S. in Computer Science or Engineering

Job description

Tempus, Inc. is seeking a Senior Quality Engineer to lead verification and validation of systems supporting Tempus Medical Devices. This role involves ensuring regulatory compliance, developing CSV policies, and collaborating with cross-functional teams. Candidates should have 5+ years in FDA regulated domains and expertise in Computer System Validation. The position is based in New York City, with a competitive pay range of $100,000-$150,000 and a full range of benefits.