Quality Engineer, Medical Devices – Design Controls

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

Job summary

CSL Vifor in United States, Massachusetts, seeks a Quality Engineer to serve as the QA representative on combination product development projects. You will participate in Design Controls, support risk management, reviews, V&V planning, change control, and DHF maintenance, ensuring compliance with FDA, EU MDR and other global regulations.

The role requires at least 3 years in quality, engineering, manufacturing, or related technical work within medical devices or biotechnology, with working

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering, life sciences, or a related discipline.
• Minimum 3 years of experience in quality, engineering, manufacturing, or related technical role within medical device, pharmaceutical, biotechnology, medtech, or combination products.
• 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.
• Effective communication and collaboration skills.
• Strong organizational and planning skills.
• Analytical and problem-solving abilities.
• Ability to work independently on routine assignments while seeking guidance on complex issues.

Responsibilities

• Serve as Quality Engineer on assigned combination product development projects as a Quality representative.
• Participate in Design Controls activities and support risk management, document reviews, verification and validation planning, change management, and DHF maintenance.
• Collaborate with project leaders and internal/external team members to ensure design development work meets regulatory requirements.
• Ensure design development teams follow Design Controls and utilize quality techniques such as risk analysis and sampling.
• Assist with oversight of external development and manufacturing partners; participate in audits and review QA agreements.
• Support maintenance and improvement of quality systems; update SOPs/WI; train on modified processes.
• Identify and communicate quality-related issues and risks.
• Support investigations, CAPAs, nonconformance management, and change controls.
• Participate in internal audits and inspection readiness activities.
• Stay informed on applicable regulations and standards.
• Maintain quality-related systems and databases (vendor certificates, test method validation log).

Skills

Quality engineering

Regulatory compliance

Design Controls

Risk management

Documentation reviews

V&V planning

Change management

Analytical skills

Cross-functional collaboration

Independent work

Education

Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline

Job description

CSL Vifor in United States, Massachusetts, seeks a Quality Engineer to serve as the QA representative on combination product development projects. You will participate in Design Controls, support risk management, reviews, V&V planning, change control, and DHF maintenance, ensuring compliance with FDA, EU MDR and other global regulations.

The role requires at least 3 years in quality, engineering, manufacturing, or related technical work within medical devices or biotechnology, with working