Associate Quality Engineer, Combo Products – Equity Options

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

Job summary

CSL Behring is seeking an Associate Quality Engineer in Waltham, MA to support CP/MD device quality activities across development and manufacturing. You will work under senior QA guidance on design controls, risk management, DHF upkeep, and regulatory alignment with FDA/EU requirements.

Qualifications include a 3+ year background in quality or engineering within medical devices or biotech, plus familiarity with 21 CFR Part 820, ISO 13485, and EU MDR.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum 3 years in quality, engineering, manufacturing or related technical role in medical devices, pharma, biotech, medtech or combination products.

Responsibilities

• Serve as Quality Engineer on CP/MD development projects, participate in Design Control and risk management, review documents, and support DHF maintenance.
• Assist oversight of external development/manufacturing partners; participate in audits and review quality or development agreements.
• Support maintenance and improvement of quality systems; propose process improvements and train on modified processes.
• Identify and communicate quality issues and risks; support investigations, CAPAs and change controls.
• Participate in internal audits and inspection readiness; stay informed on regulations and standards.

Skills

Regulatory knowledge

Design Controls

Risk management

V&V

Design transfer

Communication

Analytical thinking

Independent work

Education

Bachelor's degree in mechanical/biomedical engineering or life sciences

Job description

CSL Behring is seeking an Associate Quality Engineer in Waltham, MA to support CP/MD device quality activities across development and manufacturing. You will work under senior QA guidance on design controls, risk management, DHF upkeep, and regulatory alignment with FDA/EU requirements.

Qualifications include a 3+ year background in quality or engineering within medical devices or biotech, plus familiarity with 21 CFR Part 820, ISO 13485, and EU MDR.