Quality Systems Engineer – Complaints & Documentation

Merz Pharmaceuticals LLC in; Raleigh (NC); On-site; USD 85,000 - 115,000; Full time

Job summary

Merz Therapeutics in Raleigh, NC is seeking a Quality Engineer for Quality Systems (Finance) to support complaint management, document control, deviations, and CAPAs. The role partners with Regulatory, Safety, and cross-functional teams to ensure GMP/GDP compliance and continuous improvement.

Strong data skills with Excel, Power BI, and BI dashboards are prized, along with excellent communication in English.

Qualifications

• Bachelor's degree in Science or Engineering or equivalent experience.
• Minimum 3 years of experience in the pharmaceutical industry, preferably QA/Quality Systems.
• Experience creating quality metrics dashboards and presenting data.
• Fluency in English; strong written and verbal communication.

Responsibilities

• Support quality system functions with a focus on complaint management.
• Manage document control, training administration and SOP lifecycle.
• Assist deviations, CAPAs, and corrective actions tracking.
• Support audits, inspections and regulatory activities.
• Collaborate with cross-functional teams including Regulatory and Safety.
• Maintain compliance with GMP/GDP and company procedures.

Skills

Quality systems knowledge

Data analysis

Communication skills

Excel

Power BI

Education

Bachelor's degree in Science or Engineering

Tools

JIRA

MasterControl

TrackWise

Veeva

Power BI

Excel

Job description

Merz Therapeutics in Raleigh, NC is seeking a Quality Engineer for Quality Systems (Finance) to support complaint management, document control, deviations, and CAPAs. The role partners with Regulatory, Safety, and cross-functional teams to ensure GMP/GDP compliance and continuous improvement.

Strong data skills with Excel, Power BI, and BI dashboards are prized, along with excellent communication in English.