Packaging Quality Engineer - Medical Devices & Combos

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

Job summary

CSL in Waltham, MA is seeking a Combination Product and Medical Device QA Associate within 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 components.

The role ensures that new product development activities follow a 21 CFR Part 4 compliant QMS, works as a subject matter expert on FDA/MDR/ISO standards, collaborates with manufacturing sites, and supports risk

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum 5 years of experience in medical devices or combination products.
• Strong knowledge of 21 CFR Part 4, FDA/ MDR, ISO standards and QMS.
• Experience with risk analysis and design controls is preferred.

Responsibilities

• Serve as Medical Device and Packaging QA Associate on assigned development projects, ensuring design work meets regulatory requirements.
• Support vendor audits and manage supplier quality and development agreements.
• Provide progress reports and escalate risks to Quality management.
• Assist with development and implementation of a compliant quality system and SOPs.
• Stay updated on regulatory changes.
• Maintain systems/databases related to combination products.
• Conduct root cause analysis and problem solving.

Skills

Regulatory knowledge

Quality assurance

Design controls

Education

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

Job description

CSL in Waltham, MA is seeking a Combination Product and Medical Device QA Associate within 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 components.

The role ensures that new product development activities follow a 21 CFR Part 4 compliant QMS, works as a subject matter expert on FDA/MDR/ISO standards, collaborates with manufacturing sites, and supports risk