Quality Engineer - Medical Devices, CAPA & Validation

Pentangle Tech Services | P5 Group; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a seasoned Quality Management professional in the United States to advance medical device quality programs. You will apply CAPA, TMV, and process validation to ensure compliance and robust product quality across manufacturing processes.

You will collaborate with cross-functional teams, lead risk analyses and design controls, and ensure adherence to FDA and ISO standards while communicating findings and improvements clearly.

Qualifications

• Knowledge of medical procedures and corresponding medical equipment.
• Experience in CAPA execution and write-ups.
• Experience in Test Method Validation (TMV).
• Experience in Process Validation.
• Knowledge of medical equipment manufacturing processes.
• Knowledge of Quality Management and its tools & techniques.
• Knowledge of FDA, ISO 13485, ISO 14971 and compliance regulations.
• Knowledge of NC and audit processes.
• Knowledge in statistics, risk management and design controls.
• Excellent verbal and written communication; familiar with project management, problem solving and presentations.
• Minimum 5+ years of quality management experience in the medical device industry.

Skills

CAPA execution

TMV

Process Validation

Quality Management

FDA compliance

ISO 13485

ISO 14971

Risk management

Design controls

communication skills

project management

problem solving

presentation skills

statistics

data analysis

Tools

NCR process

AFMEA

DFMEA

PFMEA

validation protocols

CAPA tools

Statistical tools

Job description

Pentangle Tech Services | P5 Group is seeking a seasoned Quality Management professional in the United States to advance medical device quality programs. You will apply CAPA, TMV, and process validation to ensure compliance and robust product quality across manufacturing processes.

You will collaborate with cross-functional teams, lead risk analyses and design controls, and ensure adherence to FDA and ISO standards while communicating findings and improvements clearly.