Quality Engineer – Medical Devices/Pharma

Katalyst-Healthcares-; Andover (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Creative Solutions Services, LLC in Massachusetts is seeking a Quality Engineer with experience in medical devices, pharma, biotech, or other regulated industries. The role requires familiarity with quality systems, regulatory requirements, and manufacturing/validation processes.

The candidate will support CAPA, audits, change control, validation, and continuous improvement while maintaining robust documentation and data integrity across cross-functional teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field.
• 0–2 years of experience in Quality Engineering/QA.
• Experience in medical devices, pharma, biotech, or regulated industries.
• Knowledge of CAPA, 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

Communication

Analytical thinking

Documentation

Problem solving

Quality systems

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.
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.