Senior Device Quality Engineer — Lead Regulatory Quality & Safety

GSK; Zebulon (NC); Hybrid; USD 85,000 - 110,000; Full time

Job summary

GSK in Zebulon, NC is looking for a professional to ensure compliance with regulatory standards for medical devices. The role involves leading quality oversight, investigations, and maintaining risk management files. Ideal candidates should have a Bachelor's degree in a related discipline and 8+ years in the industry.

This position offers a hybrid work model, supporting personal growth and a collaborative work environment. GSK is committed to career development and an inclusive workplace.

Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline with medical device expertise.
• Minimum of 8+ years in pharmaceutical, biopharmaceutical, or related industries.
• Experience in investigations, root cause analysis, and CAPA processes.
• Working knowledge of QMS and cGMP regulations.

Responsibilities

• Ensure compliance with FDA, ISO, EU MDR, and GSK requirements for medical devices.
• Maintain risk management files and Design and Development File.
• Review technical documentation and support new product development.
• Lead investigations for device-related nonconformances and complaints.
• Trend site KPIs for device processes and support mitigation strategies.
• Act as subject matter expert for regulatory inspections and audits.

Job description

GSK in Zebulon, NC is looking for a professional to ensure compliance with regulatory standards for medical devices. The role involves leading quality oversight, investigations, and maintaining risk management files. Ideal candidates should have a Bachelor's degree in a related discipline and 8+ years in the industry.

This position offers a hybrid work model, supporting personal growth and a collaborative work environment. GSK is committed to career development and an inclusive workplace.