Quality Engineer - Regulated Med Devices & GMP

Katalyst CRO; Andover (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer with experience in medical devices, pharma, biotech, or other regulated industries. You will contribute to quality systems, regulatory compliance, and manufacturing/validation processes.

You will support CAPA, deviations, root cause analysis, and change control; participate in process validation and audits; collaborate with Engineering, Manufacturing, R&D, and Quality teams to resolve issues.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field.
• 0-2 years of experience in Quality Engineering/Quality Assurance.
• Experience in medical devices, pharma, biotech, or another regulated industry.
• Knowledge of CAPA, Client, deviations, change control, validation, audits, and quality systems.
• Strong communication, analytical, documentation, and problem-solving skills.

Responsibilities

• Support quality activities related to manufacturing processes, products, and equipment.
• Review and maintain quality documentation, SOPs, work instructions, and quality records.
• Support CAPA, client/deviations, root cause analysis, and corrective actions.
• Participate in process validation, equipment qualification, and change control activities.
• Support internal and external audits and ensure compliance with applicable regulatory requirements.
• Work with Engineering, Manufacturing, R&D, and Quality teams to identify and resolve quality issues.
• Ensure compliance with GMP/cGMP, FDA 21 CFR, ISO 13485, and other applicable standards.
• Assist with continuous improvement and maintain strong documentation and data integrity practices.

Skills

Quality systems knowledge

Regulatory compliance

CAPA & deviations

Root cause analysis

Documentation

Communication skills

Problem-solving

Education

Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field

Job description

Katalyst CRO is seeking a Quality Engineer with experience in medical devices, pharma, biotech, or other regulated industries. You will contribute to quality systems, regulatory compliance, and manufacturing/validation processes.

You will support CAPA, deviations, root cause analysis, and change control; participate in process validation and audits; collaborate with Engineering, Manufacturing, R&D, and Quality teams to resolve issues.