Regional Quality Engineer Lead - Regulatory & Design Control

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

Job summary

CSL Behring in Waltham, MA seeks a Regional Lead Quality Engineer CP/MD to ensure new product development for combination products complies with 21 CFR Part 4, FDA, MDR, and ISO standards.

You will guide CP/MD staff, collaborate with global functions and manufacturing sites, and oversee quality systems across the product lifecycle with emphasis on design controls and risk management. This role demands strong communication and stakeholder influence to drive process improvements.

Qualifications

• Requires 5+ years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Hands-on knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR and related guidance.
• Experience with design controls, risk management (FMEA), validation/verification, and design transfer.

Responsibilities

• Provide clear Quality guidance and oversight to CP/MD development projects, ensuring compliance with FDA/EU MDR and design controls.
• Ensure external partners meet CSL standards; participate in audits and review quality/development agreements.
• Provide regular progress reports and escalate risks to Quality management.
• Develop and implement quality systems compliant with 21 CFR Part 4 and MDR; update SOPs and training.
• Stay updated on evolving regulatory requirements for devices and combination products.
• Maintain systems and databases related to combination products (standards lists, vendor certificates, test method logs).
• Apply Six Sigma problem solving to resolve issues quickly.

Skills

Quality systems

Design controls

Regulatory compliance

Six Sigma

Risk analysis

Education

Bachelors in engineering

Job description

CSL Behring in Waltham, MA seeks a Regional Lead Quality Engineer CP/MD to ensure new product development for combination products complies with 21 CFR Part 4, FDA, MDR, and ISO standards.

You will guide CP/MD staff, collaborate with global functions and manufacturing sites, and oversee quality systems across the product lifecycle with emphasis on design controls and risk management. This role demands strong communication and stakeholder influence to drive process improvements.