Remote Quality Engineer II-Medical Devices & Design Control

Fresenius Medical Care; United States; Remote; USD 150.000 - 158.000; Vollzeit

Zusammenfassung

Fresenius Medical Care is seeking a Quality Engineer II for NxStage Medical, Inc. in Waltham, MA (Remote). The role applies biomedical systems engineering and QA to product development lifecycles, focusing on design assurance and postmarket issues.

Responsibilities include investigating complaints, supplier quality, and performing audits to regulations and standards. Telecommuting from anywhere in the United States is supported.

Qualifikationen

• Bachelor’s or Master’s in Biomedical Engineering or closely related field with required years of medical device experience.
• Experience with ISO14971, 21 CFR Part 820 and ISO 13485.
• Experience investigating medical device product complaints and performing RCA/CAPA.

Aufgaben

• Support biomanufacturing teams to investigate manufacturing problems and root cause.
• Process medical device complaints and maintain open complaints.
• Maintain quality data databases and prepare periodic reports.
• Provide QA oversight to design and development of new products and production processes.
• Assist with MRB, nonconformance handling, and CAPA disposition.

Kenntnisse

Root Cause Analysis

CAPA

Risk Management

Design Control

Regulatory compliance

Auditing

Ausbildung

Bachelor’s in Biomedical Engineering

Master’s in Biomedical Engineering

Tools

Minitab

Gage R&R

Change Control

Jobbeschreibung

Fresenius Medical Care is seeking a Quality Engineer II for NxStage Medical, Inc. in Waltham, MA (Remote). The role applies biomedical systems engineering and QA to product development lifecycles, focusing on design assurance and postmarket issues.

Responsibilities include investigating complaints, supplier quality, and performing audits to regulations and standards. Telecommuting from anywhere in the United States is supported.