Senior Device Quality Engineer — Lead Quality & Compliance

GlaxoSmithKline; Zebulon (NC); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Career development support

Mentorship opportunities

Inclusive workplace environment

Job summary

GlaxoSmithKline in Zebulon, North Carolina is hiring a quality assurance professional for medical devices. This role focuses on ensuring compliance with FDA and ISO standards while leading investigations into nonconformances.

The ideal candidate will have over 8 years of experience in pharma or biopharma with strong skills in risk management and communication. You’ll be part of a team that values quality and patient safety, with opportunities for personal growth in a hybrid work environment.

Qualifications

• 8+ years of experience in pharmaceutical or biopharmaceutical industries.
• Hands-on experience with CAPA processes and investigations.
• Knowledge of current Good Manufacturing Practice (cGMP) regulations.

Responsibilities

• Ensure compliance with FDA, ISO, and GSK requirements for medical devices.
• Review and approve technical documentation.
• Lead investigations for device-related nonconformances.

Skills

Investigation and root cause analysis

Regulatory compliance

Quality Management Systems (QMS)

Communication skills

Risk management

Education

Bachelor's degree in a scientific, engineering or technical discipline

Advanced degree in Engineering or Biomedical Engineering (preferred)

Tools

ISO 14971

ISO 13485

FMEA

Statistical analysis software

Job description

GlaxoSmithKline in Zebulon, North Carolina is hiring a quality assurance professional for medical devices. This role focuses on ensuring compliance with FDA and ISO standards while leading investigations into nonconformances.

The ideal candidate will have over 8 years of experience in pharma or biopharma with strong skills in risk management and communication. You’ll be part of a team that values quality and patient safety, with opportunities for personal growth in a hybrid work environment.