Quality Engineer - Design Controls & Compliance (MedTech)

CSL Plasma; Waltham (MA); On-site; USD 94,000 - 111,000; Full time

Job summary

CSL Plasma in the United States is seeking a Quality Engineer to drive design controls, risk management, and DHF maintenance on combination product projects. You will participate in design reviews and ensure compliance with FDA, EU MDR and global regulatory requirements.

You will oversee external development and manufacturing partners, support vendor audits, and help maintain continuous improvement of quality systems.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum 3 years of experience in a quality, engineering, manufacturing, or related technical role within medical device, pharmaceutical, biotechnology, medtech, or combination products industries.
• Working knowledge of 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU MDR; familiarity with Design Controls, risk management, V&V, and design transfer.

Responsibilities

• Serve as Quality Engineer on design development projects and ensure regulatory compliance.
• Oversee external development and manufacturing partners and participate in audits.
• Maintain and improve quality systems; update SOPs/Forms and train on new processes.
• Identify and communicate quality-related issues and risks.
• Support investigations, CAPAs, nonconformance, and change controls.
• Participate in internal audits and inspection readiness.
• Stay informed on applicable regulations and standards.
• Maintain quality-related systems and databases.

Skills

Quality engineering

Design Controls

Risk management

Regulatory knowledge

Communication

Education

Bachelor's degree in mechanical or biomedical engineering

Job description

CSL Plasma in the United States is seeking a Quality Engineer to drive design controls, risk management, and DHF maintenance on combination product projects. You will participate in design reviews and ensure compliance with FDA, EU MDR and global regulatory requirements.

You will oversee external development and manufacturing partners, support vendor audits, and help maintain continuous improvement of quality systems.