Quality Systems Engineer - GxP & Compliance

BioIVT; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

BioIVT in the United States seeks a Quality Engineer to promote a culture of quality across the organization. You will ensure products, processes, and systems meet regulatory standards and customer expectations.

The role focuses on developing and maintaining QMS, SOPs, training, and documentation, while guiding cross-functional teams in GDP, GLP, cGMP, and FDA compliance. A strong communicator with attention to detail will help prepare for inspections and drive continuous improvement within

Qualifications

• Knowledge of GDP/GLP/cGMP and FDA regulations.
• Experience creating and maintaining SOPs and training materials.
• Familiarity with internal and external audits.
• Strong documentation and record-keeping skills.

Responsibilities

• Develop, implement, and maintain GxP QMS for BioIVT sites.
• Establish quality programs to monitor product quality and compliance.
• Prepare for internal, customer, and regulatory inspections.
• Support audit programs and produce audit reports.

Skills

GxP Quality Management

Regulatory Compliance

Documentation & SOPs

Audit & Inspection

Job description

BioIVT in the United States seeks a Quality Engineer to promote a culture of quality across the organization. You will ensure products, processes, and systems meet regulatory standards and customer expectations.

The role focuses on developing and maintaining QMS, SOPs, training, and documentation, while guiding cross-functional teams in GDP, GLP, cGMP, and FDA compliance. A strong communicator with attention to detail will help prepare for inspections and drive continuous improvement within