Packaging & Medical Device QA Engineer

CSL Plasma Inc.; Waltham, Northern (MA, KY); Hybrid; USD 115,000 - 136,000; Full time

Benefits offered by this job

Incentive compensation

Equity

Job summary

CSL Behring is seeking a Combination Product and Medical Device and Packaging QA Associate in the CP/MD QA department to represent Quality in global teams across design, development, manufacture and regulatory approval of CSL combination products, including medical device parts.

The role ensures that design development activities follow 21 CFR Part 4 and MDR, collaborates with multiple sites, provides risk analysis, updates SOPs and training, and stays current with regulatory changes to support

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum 5 years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Experience with FDA/EU MDR regulatory requirements and Design Controls.
• Strong root cause analysis, problem solving and risk management skills.

Responsibilities

• Represent Quality in global teams to ensure design development meets regulatory requirements.
• Support vendor management and audits; review quality or development agreements.
• Provide progress updates and escalate risks to Quality management.
• Develop and implement a quality system compliant with 21 CFR Part 4, MDR and global requirements; update SOPs/WIs/Forms and train on changes.
• Stay updated on changing regulatory requirements for medical devices and combination products.
• Maintain systems/databases related to combination products and vendor records.
• Conduct root cause analysis and implement effective corrective actions.

Skills

Quality engineering

Design Controls

Regulatory compliance

Root cause analysis

Vendor management

Education

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

Job description

CSL Behring is seeking a Combination Product and Medical Device and Packaging QA Associate in the CP/MD QA department to represent Quality in global teams across design, development, manufacture and regulatory approval of CSL combination products, including medical device parts.

The role ensures that design development activities follow 21 CFR Part 4 and MDR, collaborates with multiple sites, provides risk analysis, updates SOPs and training, and stays current with regulatory changes to support