Regional Lead QA Engineer – Medical Devices

BioSpace; Waltham (MA); On-site; USD 143,000 - 169,000; Full time

Job summary

CSL Behring is seeking a Regional Lead Quality Engineer CP/MD to oversee quality activities for combination product development, ensuring compliance with 21 CFR Part 4 and global standards. You will guide CP/MD staff and collaborate with global teams across multiple sites to drive design controls and lifecycle quality coverage.

You will apply risk management, V&V, and design transfer practices while maintaining quality systems, vendor oversight, and continuous process improvements in a

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or relevant discipline.
• Minimum 5 years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Strong knowledge of global regulatory requirements (FDA/ISO/EU MDR) and Design Control processes.

Responsibilities

• Provide clear Quality guidance and oversight to assigned CP/MD development projects ensuring compliance with FDA, EU MDR, and other global regulations.
• Ensure external development and manufacturing partners meet CSL standards; participate in vendor audits and review quality agreements.
• Provide regular progress reports and escalate potential risks to Quality management and stakeholders.
• Develop and implement a compliant quality system per 21 CFR Part 4, MDR, and other global requirements; update SOPs/WIs/Forms and train staff.
• Stay updated on changing regulatory requirements for medical devices and combination products.
• Maintain systems/databases (standards, vendor certificates, test method validation logs) for CP/MD.
• Apply six sigma problem solving to identify and resolve issues promptly.

Skills

Quality Engineering

Regulatory Knowledge

Design Controls

Risk Analysis

Vendor Management

Six Sigma

Project Leadership

Communication

Problem Solving

Education

Bachelor’s degree in mechanical or biomedical engineering

Job description

CSL Behring is seeking a Regional Lead Quality Engineer CP/MD to oversee quality activities for combination product development, ensuring compliance with 21 CFR Part 4 and global standards. You will guide CP/MD staff and collaborate with global teams across multiple sites to drive design controls and lifecycle quality coverage.

You will apply risk management, V&V, and design transfer practices while maintaining quality systems, vendor oversight, and continuous process improvements in a