Packaging & Medical Device QA Engineer: Design Controls Expert

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

Job summary

CSL Behring is seeking a Quality Associate for CP/MD QA to ensure that combination product projects meet FDA, EU MDR, and global regulatory requirements throughout design, development, and lifecycle stages. The role requires collaboration across global teams and sites, with emphasis on design controls, risk management, and QMS compliance.

The ideal candidate has 5+ years in medical devices or combination products, strong communication skills, and experience with embedded software or connected

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum of 5 years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.

Responsibilities

• Serve as Medical Device and Packaging QA Associate on assigned combination product development projects and ensure design development meets FDA/EU MDR and other global regulatory requirements.
• Support vendor management activities by audits and reviewing quality/development agreements.
• Develop and implement a quality system compliant with 21 CFR Part 4, MDR and other global requirements; update SOPs/WIs/Forms and conduct training.

Skills

Design Controls

Risk Management

Quality Assurance

FDA MDR

Quality System

Root Cause

Education

Bachelors in Engineering

Life Sciences

Job description

CSL Behring is seeking a Quality Associate for CP/MD QA to ensure that combination product projects meet FDA, EU MDR, and global regulatory requirements throughout design, development, and lifecycle stages. The role requires collaboration across global teams and sites, with emphasis on design controls, risk management, and QMS compliance.

The ideal candidate has 5+ years in medical devices or combination products, strong communication skills, and experience with embedded software or connected