Packaging Quality Engineer – Medical Devices & Combination Products

BioSpace; Waltham (MA); On-site; USD 115,000 - 136,000; Full time

Job summary

CSL Behring is seeking a Quality Associate for Combination Product and Medical Device QA in the United States (Waltham, MA) to ensure 21 CFR Part 4 compliance and design controls across global development and manufacturing activities.

The role requires at least 5 years in medical devices or combination products, strong knowledge of ISO 13485/14971, and collaboration with cross-functional teams. Base salary range is $115,000–$136,000 with potential incentives.

Qualifications

• Expert knowledge of FDA quality systems and 21 CFR Part 4 and MDR requirements.
• Minimum 5 years of experience in medical devices or combination products.
• Strong communication and collaboration skills.

Responsibilities

• Work on assigned combination product development projects to meet regulatory requirements.
• Ensure external partners meet CSL standards through audits and agreements.
• Provide progress updates and flag risks to management.
• Help develop and implement compliant quality systems and SOPs.
• Stay current with regulatory changes affecting devices and combination products.
• Maintain databases and systems related to combination products.
• Perform root cause analysis and implement corrective actions.

Skills

Regulatory knowledge

Quality engineering

Design controls

Cross-functional communication

Problem solving

Education

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

Tools

FDA regulations

Quality management systems

Job description

CSL Behring is seeking a Quality Associate for Combination Product and Medical Device QA in the United States (Waltham, MA) to ensure 21 CFR Part 4 compliance and design controls across global development and manufacturing activities.

The role requires at least 5 years in medical devices or combination products, strong knowledge of ISO 13485/14971, and collaboration with cross-functional teams. Base salary range is $115,000–$136,000 with potential incentives.