Senior Quality Engineer – Medical Devices, GMP/ISO, CAPA

Tecomet; Wilmington (MA); Presencial; USD 100.000 - 135.000; Jornada completa

Descripción de la vacante

Tecomet in Massachusetts is seeking a Sr. Quality Engineer to drive quality systems, process control and regulatory compliance across manufacturing operations.

You will maintain FDA/ISO compliant programs, support MRB, CAPA, PPAP, and lead quality improvements with Six Sigma tools while interfacing with internal and external customers to meet quality, cost and schedule targets. Ideal candidates have experience in medical device manufacturing and ASQ CQE; strong problem solving, GD&T, and

Formación

• Bachelor's degree required or equivalent in quality or related field.
• ASQ CQE or CMQ/QE preferred.
• 4 years’ quality experience in medical device manufacturing preferred.
• ISO 13485, FDA 820 familiarity preferred.

Responsabilidades

• Maintain quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Collaborate with manufacturing/operations to resolve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, PPAPs.
• Coordinate process validations and reduce inspection reliance.
• Generate quality metrics and cost of quality reports.
• Investigate customer complaints and implement CAPA and corrective actions.
• Write and maintain quality-related procedures.

Conocimientos

Manufacturing operations

Quality Systems

FDA GMP ISO

GD&T

Problem solving

8D

MS Office

Educación

Bachelor’s degree in quality

Descripción del empleo

Tecomet in Massachusetts is seeking a Sr. Quality Engineer to drive quality systems, process control and regulatory compliance across manufacturing operations.

You will maintain FDA/ISO compliant programs, support MRB, CAPA, PPAP, and lead quality improvements with Six Sigma tools while interfacing with internal and external customers to meet quality, cost and schedule targets. Ideal candidates have experience in medical device manufacturing and ASQ CQE; strong problem solving, GD&T, and