Associate Quality Engineer — CP/MD Product Development

CSL Plasma; Waltham (MA); On-site; USD 94,000 - 111,000; Full time

Job summary

CSL Behring in Waltham, MA seeks an Associate Quality Engineer to support CP/MD development and regulatory activities, ensuring compliance with FDA and EU MDR standards. You will work with global teams to maintain quality systems and DHF/DSF documentation.

Under supervision, you will participate in Design Controls, risk management, and V&V, assist audits, CAPAs, and supplier oversight, and contribute to continuous improvement of quality processes across sites.

Qualifications

• 3+ years in quality, engineering, manufacturing, or related role in medical devices or combination products.
• Knowledge of 21 CFR Part 820, Part 4, ISO 13485, ISO 14971 and EU MDR.
• Experience with Design Controls, risk management, V&V, and design transfer.
• Strong communication and collaboration skills; able to work cross-functionally.

Responsibilities

• Serve as Quality Engineer on CP/MD development projects and ensure regulatory compliance.
• Support audits, vendor management, and QMS maintenance.
• Assist in CAPAs, nonconformances, change controls, and investigations.
• Maintain DHF, quality systems, and related databases.
• Participate in internal audits and inspection readiness.
• Stay updated on applicable regulations and standards.
• Collaborate with cross-functional teams across sites.

Skills

Design Controls

Risk Analysis

Verification & Validation

CAPA

Audit Readiness

Vendor Management

Regulatory Compliance

Education

Bachelor's degree in mechanical or biomedical engineering

Job description

CSL Behring in Waltham, MA seeks an Associate Quality Engineer to support CP/MD development and regulatory activities, ensuring compliance with FDA and EU MDR standards. You will work with global teams to maintain quality systems and DHF/DSF documentation.

Under supervision, you will participate in Design Controls, risk management, and V&V, assist audits, CAPAs, and supplier oversight, and contribute to continuous improvement of quality processes across sites.