Quality Engineer, Design Controls for Combo Med Devices

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

Benefits offered by this job

Incentive compensation

Equity

Job summary

CSL Behring is seeking an Associate Quality Engineer to support quality activities across global teams involved in combination product development, manufacturing, and regulatory approval. You will work under senior team members to ensure compliance with quality systems, including 21 CFR Part 4, and collaborate with manufacturing sites to maintain compliant processes.

The role reports to the Regional Product Development Quality Lead and has no direct reports.

Qualifications

• Strong communication and collaboration skills.
• Excellent organizational and planning abilities.
• Analytical and problem-solving capabilities.
• Ability to work independently on routine tasks while seeking guidance on complex issues.

Responsibilities

• Serve as Quality Engineer on assigned combination product development projects and participate in Design Control activities.
• Support risk management, document reviews, verification/validation planning, change management and DHF maintenance.
• Collaborate with internal and external team members to ensure design development complies with FDA, EU MDR and global requirements.
• Assist with oversight of external development and manufacturing partners; participate in audits and review quality/development agreements.
• Support maintenance and continuous improvement of quality systems; update SOPs/WIs/Forms and train on modified processes.
• Identify and communicate quality 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 databases such as vendor certificates and test method validation logs.

Skills

Communication

Collaboration

Organizational skills

Problem-solving

Independent work

Education

Bachelor degree in mechanical or biomedical engineering or life sciences

Job description

CSL Behring is seeking an Associate Quality Engineer to support quality activities across global teams involved in combination product development, manufacturing, and regulatory approval. You will work under senior team members to ensure compliance with quality systems, including 21 CFR Part 4, and collaborate with manufacturing sites to maintain compliant processes.

The role reports to the Regional Product Development Quality Lead and has no direct reports.