Quality Engineer, Medical Devices — Design Controls & Risk

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

Job summary

CSL Plasma is seeking a Quality Engineer to join our combination product development projects as a quality representative. You will participate in Design Controls, support risk management, verification/validation planning, change management, and DHF maintenance, ensuring compliance with FDA, EU MDR and other global requirements.

Collaborate with project leaders and internal/external teams to ensure development work meets regulatory standards; apply quality engineering techniques such as risk

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or life sciences.
• Minimum 3 years in quality, engineering, manufacturing, or related technical roles in medical device or combination products.
• Working knowledge of 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 and EU MDR.

Responsibilities

• Serve as Quality Engineer on combination product development projects and participate in Design Control activities.
• Assist with oversight of external development and manufacturing partners and vendor audits.
• Support maintenance and continuous improvement of quality systems and SOPs.
• Identify and communicate quality issues and risks.
• Support investigations, CAPAs, nonconformance management, and change controls.
• Participate in internal audits and inspection readiness.
• Stay informed on applicable regulations and standards.
• Maintain quality-related systems and databases.

Education

Bachelor’s degree in mechanical or biomedical engineering

Job description

CSL Plasma is seeking a Quality Engineer to join our combination product development projects as a quality representative. You will participate in Design Controls, support risk management, verification/validation planning, change management, and DHF maintenance, ensuring compliance with FDA, EU MDR and other global requirements.

Collaborate with project leaders and internal/external teams to ensure development work meets regulatory standards; apply quality engineering techniques such as risk