Quality Systems Engineer - Patient-First QA & Compliance

Merz Pharmaceuticals, LLC; Raleigh (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Merz Therapeutics, a private, family-owned company, seeks a Quality Engineer to support quality system functions with a focus on technical product quality complaint management.

Responsibilities include complaint intake, data processing, case tracking, investigations, and customer responses, plus training and document control system support. 3+ years pharma QA required; familiarity with Power BI/Tableau is a plus.

Qualifications

• Minimum 3 years in pharmaceutical QA or quality systems.
• Experience with quality metrics dashboards (Power BI/Tableau) and data analysis.
• Knowledge of GMP, GDP and regulatory requirements.
• Proficiency in MS Office and QA document systems.

Responsibilities

• Manage quality system complaints lifecycle from intake to closeout.
• Support document control and training lifecycle management.
• Assist deviations, CAPAs and trend analysis.
• Prepare QA policies and procedures and assist audits.
• Coordinate with Regulatory, Safety and cross-functional teams.
• Maintain quality records and reporting metrics.

Skills

Quality systems

GMP/GDP knowledge

Fluency in English

Communication skills

Education

Bachelors in Science/Engineering

Tools

Power BI

Tableau

Excel

JIRA

MasterControl

TrackWise

Veeva

Job description

Merz Therapeutics, a private, family-owned company, seeks a Quality Engineer to support quality system functions with a focus on technical product quality complaint management.

Responsibilities include complaint intake, data processing, case tracking, investigations, and customer responses, plus training and document control system support. 3+ years pharma QA required; familiarity with Power BI/Tableau is a plus.