Senior Quality Engineer - Med Devices & Process

Katalyst CRO; Danvers (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Senior Quality Engineer in Danvers, Massachusetts, who will provide comprehensive quality support for commercial medical devices. The ideal candidate must have a Bachelor's degree in Engineering, Sciences, or a related field with 5-7 years of relevant experience, especially in medical device design and development. Key responsibilities include ensuring compliance with quality standards, performing statistical analysis, and collaborating with engineering functions. Preferred qualifications include Six Sigma certification and familiarity with Quality System Regulations.

Qualifications

• 5-7 years of experience in Engineering and/or Quality or 2 years with Advanced Degree.
• Experience in medical device design and development.
• Hands-on in upstream product development and downstream operations quality.

Responsibilities

• Provide quality engineering support for medical device products.
• Develop and maintain quality standards for processing materials.
• Collaborate with engineering and manufacturing to ensure quality standards.

Skills

Quality Engineering principles

Test method validation

Statistical analysis

Risk management

Quality tools including FMEA

Document control

Six Sigma

Education

Bachelor's Degree in Engineering, Science or technical field

Advanced Degree in Engineering, Science or technical field

Tools

SAP QM

SPC software

Job description

Katalyst CRO is seeking a Senior Quality Engineer in Danvers, Massachusetts, who will provide comprehensive quality support for commercial medical devices. The ideal candidate must have a Bachelor's degree in Engineering, Sciences, or a related field with 5-7 years of relevant experience, especially in medical device design and development. Key responsibilities include ensuring compliance with quality standards, performing statistical analysis, and collaborating with engineering functions. Preferred qualifications include Six Sigma certification and familiarity with Quality System Regulations.