Quality Engineer II, Medical Devices — Remote

Fresenius Medical Care; Waltham (MA); Remote; USD 150,000 - 158,000; Full time

Job summary

NxStage Medical seeks a Quality Engineer to apply biomedical systems engineering and QA methods across product development lifecycles and postmarket issues. You will test medical devices, oversee service activities, and drive supplier quality and audits to regulatory standards.

The role requires a biomedical engineering background with experience in medical device quality systems, CAPA, PFMEA, and risk analysis. Telecommuting from anywhere in the United States is supported.

Qualifications

• Requires a Biomedical Engineering degree with 5 years in medical device quality engineering.
• Experience investigating medical device complaints and performing CAPAs is required.
• Familiarity with ISO 14971, 21 CFR Part 820 and ISO 13485 is essential.

Responsibilities

• Apply biomedical systems engineering and QA principles to product development lifecycles.
• Test medical devices and oversee postmarket service activities.
• Perform supplier quality activities and supplier audits to GMP/quality standards.
• Develop risk management and design control documentation (PFMEA, DV/Validation).
• Lead MRB processes, nonconformances, and CAPA actions.
• Support design and development for new products and production processes.

Skills

ISO14971

21 CFR 820

ISO 13485

Minitab

Gage R&R

Change Control

DFMEA

CAPA

Risk analysis

Education

Bachelor’s degree in Biomedical Engineering

Master’s degree in Biomedical Engineering

Tools

Design Verification

Validation testing

Job description

NxStage Medical seeks a Quality Engineer to apply biomedical systems engineering and QA methods across product development lifecycles and postmarket issues. You will test medical devices, oversee service activities, and drive supplier quality and audits to regulatory standards.

The role requires a biomedical engineering background with experience in medical device quality systems, CAPA, PFMEA, and risk analysis. Telecommuting from anywhere in the United States is supported.