Senior Quality Engineer: Medical Devices QA Leader

TriSalus Life Sciences, Inc.; Westminster (CO); Presencial; USD 100.000 - 120.000; Jornada completa

Descripción de la vacante

TriSalus Life Sciences, Inc. in Westminster, CO is seeking a Senior Quality Engineer to serve as the technical authority for quality engineering across the product lifecycle.

This role leads enterprise-wide quality initiatives, mentors engineers, and ensures alignment with FDA regulations and ISO 13485 requirements. The Senior QE will own supplier quality, process validation, sterility assurance, and CAPA programs, driving cross-functional projects with minimal supervision in a fast-paced

Formación

• BS in Engineering, Science, Biomedical, or related field.
• CQA or Lead Assessor certification required.
• CQE certification preferred.
• ASQ Certified Quality Engineer (CQE) or equivalent strongly preferred.
• Valid passport required.

Responsabilidades

• Own supplier quality management program enterprise-wide. Define supplier performance standards and drive corrective actions.
• Lead manufacturing quality engineering and develop inspection plans to drive root cause analysis for complex defects.
• Lead process validation and monitoring programs (IQ/OQ/PQ, TPM, Gage R&R) and develop quality plans.
• Serve as SME for sterilization strategy, validate testing services, and guide regulatory compliance.

Conocimientos

Quality engineering

Regulatory compliance

Root cause analysis

Statistical techniques

Project leadership

Documentation excellence

Communication skills

Mentoring

Educación

BS in Engineering/Science/Biomedical

CQA or Lead Assessor certification

CQE certification preferred

ASQ CQE

Passport required

Herramientas

Minitab

Microsoft Excel

SharePoint

PowerPoint

Word

Teams

Descripción del empleo

TriSalus Life Sciences, Inc. in Westminster, CO is seeking a Senior Quality Engineer to serve as the technical authority for quality engineering across the product lifecycle.

This role leads enterprise-wide quality initiatives, mentors engineers, and ensures alignment with FDA regulations and ISO 13485 requirements. The Senior QE will own supplier quality, process validation, sterility assurance, and CAPA programs, driving cross-functional projects with minimal supervision in a fast-paced