Regional Lead Quality Engineer (Med Devices)

Biopharma Careers; Waltham (MA); On-site; USD 110,000 - 165,000; Full time

Job summary

CSL Behring seeks a Regional Lead Quality Engineer for CP/MD to ensure development activities adhere to a 21 CFR Part 4 compliant QMS across FDA/EU MDR, ISO and related standards. You will guide CP/MD staff and collaborate with global manufacturing sites to achieve quality objectives.

The role oversees site quality systems, drives design controls, risk management (FMEA), vendor audits, and continuous process improvements, with periodic domestic and international travel.

Qualifications

• Requires knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, applicable FDA guidance and QMS applications.
• Minimum 2 years practical experience in medical devices R&D quality: design controls, NPD lifecycle, risk management (FMEA), V&V, usability studies, DHFs, design transfer.

Responsibilities

• Provide clear Quality guidance to assigned CP/MD development projects and ensure design development meets FDA/EU MDR and global regulatory requirements.
• Ensure external medical device development and manufacturing partners meet CSL standards; participate in audits and review quality/development agreements.

Skills

Regulatory compliance

Quality engineering

Design controls

Risk analysis

Vendor management

Communication

Collaboration

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Job description

CSL Behring seeks a Regional Lead Quality Engineer for CP/MD to ensure development activities adhere to a 21 CFR Part 4 compliant QMS across FDA/EU MDR, ISO and related standards. You will guide CP/MD staff and collaborate with global manufacturing sites to achieve quality objectives.

The role oversees site quality systems, drives design controls, risk management (FMEA), vendor audits, and continuous process improvements, with periodic domestic and international travel.