Med Devices & Packaging QA Engineer (Design Controls)

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

Job summary

CSL Behring is seeking a Quality for Combination Products and Medical Devices Associate to support global teams in design, development, manufacture and regulatory approval of combination products. The role emphasizes FDA/EU MDR compliance and robust Design Controls.

Ideal candidates have at least 5 years in medical devices or combination products quality, with experience in risk management, V&V, and DHFs, plus collaboration across functions and sites.

Qualifications

• Minimum 5 years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Experience with FDA/ISO design control processes and risk management (FMEA).
• Familiarity with V&V, usability studies, DHFs and design transfer.

Responsibilities

• Represent Quality on assigned combination product development projects and ensure design work meets FDA, EU MDR and global requirements.
• Participate in audits of external partners and review quality or development agreements; monitor vendor performance.
• Provide progress reports and escalate risks related to Quality System or project status to management.

Skills

Quality Assurance

Design Controls

Risk Management

V&V

Usability Studies

Education

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

Job description

CSL Behring is seeking a Quality for Combination Products and Medical Devices Associate to support global teams in design, development, manufacture and regulatory approval of combination products. The role emphasizes FDA/EU MDR compliance and robust Design Controls.

Ideal candidates have at least 5 years in medical devices or combination products quality, with experience in risk management, V&V, and DHFs, plus collaboration across functions and sites.