Remote Quality Engineer, Medical Devices & QMS

Pharmavise Corporation; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Pharmavise Corporation seeks a Quality Engineer to ensure medical device products and processes comply with FDA QSR, ISO 13485, and ISO 14971. You will supervise design controls, risk management, DHF maintenance, and change control across the full product lifecycle.

You will collaborate with R&D, Regulatory, Manufacturing, and Suppliers to support audits, CAPA, validation (IQ/OQ/PQ), and supplier qualification, while applying Lean Six Sigma and SPC to drive continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in regulated medical device environment with FDA QSR, ISO 13485, ISO 14971.
• Hands-on experience in process validation, CAPA, risk management, nonconformance investigations, and audit support.

Responsibilities

• Support design controls and ensure V&V meet requirements.
• Lead CAPA and risk management activities.
• Review DHF, change controls, and PPAP.
• Support supplier qualification and audits.
• Utilize SPC and data analysis for improvements.

Skills

Quality engineering

Regulatory knowledge

CAPA

Risk management

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

MasterControl

TrackWise

Veeva

Job description

Pharmavise Corporation seeks a Quality Engineer to ensure medical device products and processes comply with FDA QSR, ISO 13485, and ISO 14971. You will supervise design controls, risk management, DHF maintenance, and change control across the full product lifecycle.

You will collaborate with R&D, Regulatory, Manufacturing, and Suppliers to support audits, CAPA, validation (IQ/OQ/PQ), and supplier qualification, while applying Lean Six Sigma and SPC to drive continuous improvement.