Senior Quality & Validation Engineer — Quality Systems Lead

ARCH; Memphis (TN); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

ARCH Medical Solutions in Bartlett, TN is seeking a Senior Quality & Validation Engineer to lead the engineering aspects of the quality function. You will handle customer inquiries, provide technical assistance, and train production teams while ensuring compliance with QA systems.

The role includes defining inspection methods, participating in CAPA, and supporting receiving and in-process inspections for new products. Strong expertise in CMM, ISO 13485, and FDA QSR is essential.

Formación

• Broad knowledge of FDA Quality System Regulations and ISO 13485.
• Proficient with CMM, surface plate technology, shop math, and inspection instruments.
• Strong analytical skills and the ability to express technical concepts clearly.
• Proficient at data collection, analysis, and presentation.
• Excellent computer skills with MS Office.
• Strong communication skills to work with customers.

Responsabilidades

• Responsible for all engineering aspects of the quality function.
• Responds to customer quality inquiries and provides technical assistance.
• Provides training to production and manufacturing engineering personnel.
• Participates in the Contract Review process to address customer requirements.
• Prepares quality control plans and IMS sheets.
• Defines inspection methods and selecting gauges for inspections.
• Participates in corrective actions including RCA, CAPA.
• Assists with receiving, in-process, and final inspections for new products.
• Ensures activities comply with the Quality Management System.
• Creates and maintains quality system documentation.
• Recommends and implements new part verification technologies.
• Understands and implements advanced Quality Software; CMM and Vision System Programming.

Conocimientos

Quality engineering

CMM

Blueprints

Data analysis

Communication

MS Office

Educación

Bachelor degree

Herramientas

CMM software

Vision system

Inspection gauges

Descripción del empleo

ARCH Medical Solutions in Bartlett, TN is seeking a Senior Quality & Validation Engineer to lead the engineering aspects of the quality function. You will handle customer inquiries, provide technical assistance, and train production teams while ensuring compliance with QA systems.

The role includes defining inspection methods, participating in CAPA, and supporting receiving and in-process inspections for new products. Strong expertise in CMM, ISO 13485, and FDA QSR is essential.