Quality Engineer: ISO 13485 & CAPA Leader (On-site)

MidAtlantic Employers' Association; Morgantown (PA); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Azer Scientific in Morgantown, PA, is seeking a Quality Engineer to drive continual improvement of the Quality Management System and ensure compliance with ISO 13485:2016 and 21 CFR 820. This on-site role supports customer requirements, internal procedures, and product quality across all finished goods.

The ideal candidate has a Bachelor's in Engineering or 3–5 years of equivalent experience, plus knowledge of cGMP and CAPA processes.

Formación

• Bachelor’s degree in Engineering or 3–5 years of equivalent experience.
• Certified Quality Auditor (CQA) recommended.
• Risk assessment management based on ISO 14791:2019 preferred.

Responsabilidades

• Manage customer complaints, create cases/tickets and communicate with customers to provide post-delivery support.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventive actions (CAPAs).
• Initiate and lead actions to prevent nonconformities relating to product, process, and QMS.
• Manage Process validation, tests, controls, documentation and improvements as needed.
• Manage calibration process of internal devices.
• Create, review, and implement processes, procedures and other documentation including SOPs, Work Instructions & forms.
• Participate in New product design process and discuss/update Product specifications and raw materials.
• Support on vendor qualification process, perform vendor audits, and prepare quality reports.
• Create Nonconforming reports for vendor issues and communicate with vendors to request corrective actions.
• Follow and improve QMS procedures to ensure manufactured products meet requirements.
• Coordinate employee training & maintain records related to the QMS.
• Perform other duties as assigned.

Conocimientos

cGMP

FMEA

Decision making

Leadership

Time management

Organizational skills

Numerical skills

Educación

Bachelor’s degree in Engineering

Certified Quality Auditor (CQA)

ISO 14791:2019 risk assessment (preferred)

Herramientas

NetSuite

Microsoft ERP

Descripción del empleo

Azer Scientific in Morgantown, PA, is seeking a Quality Engineer to drive continual improvement of the Quality Management System and ensure compliance with ISO 13485:2016 and 21 CFR 820. This on-site role supports customer requirements, internal procedures, and product quality across all finished goods.

The ideal candidate has a Bachelor's in Engineering or 3–5 years of equivalent experience, plus knowledge of cGMP and CAPA processes.