Quality Engineer

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

Summary

We are currently looking for Quality Engineers with experience in the medical device, pharmaceutical, biotechnology, or other regulated industries. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and manufacturing/validation processes.

• 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.

Summary

We are currently looking for Quality Engineers with experience in the medical device, pharmaceutical, biotechnology, or other regulated industries. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and manufacturing/validation processes.

Roles & 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.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a 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.