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Regional Lead Quality Engineer; Med Devices

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Biopharma Careers
Full Time position
Listed on 2026-09-03
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 165000 USD Yearly USD 110000.00 165000.00 YEAR
Job Description & How to Apply Below
Position: Regional Lead Quality Engineer (Med Devices)

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.

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