Global Medical Device Quality & Packaging Engineer

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

Job summary

CSL Plasma is seeking a Medical Device and Packaging QA Staff (Advisor) within the CP/MD QA department. You will ensure that design development activities for CSL combination products meet FDA, EU MDR, and other global regulatory requirements while adhering to Design Controls.

This role involves collaborating with global teams across the product lifecycle, applying risk management (FMEA), validation/verification, and quality engineering techniques, and supporting audits and process improvements

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.
• Working knowledge of medical device and combination product regulations (21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR) and related quality systems.

Responsibilities

• Serve as Medical Device and Packaging QA Associate on assigned combination product development projects and ensure compliance with FDA and MDR requirements.
• Support vendor management activities: audits, quality/development agreements, and vendor performance monitoring.
• Provide regular progress reports and escalate risks related to Quality System or project status.
• Assist with development and implementation of a quality system compliant with 21 CFR Part 4, MDR and global requirements; update SOPs/WIs/Forms and conduct training.
• Stay abreast of changing regulatory requirements for medical devices and combination products.
• Maintain systems/databases related to combination products (standards list, vendor certificates, test method validation log).
• Conduct root cause analysis and problem solving with recommendations.

Skills

Design Controls

Risk Analysis / FMEA

Validation / Verification

Usability / Human factors

Design transfer

Education

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

Job description

CSL Plasma is seeking a Medical Device and Packaging QA Staff (Advisor) within the CP/MD QA department. You will ensure that design development activities for CSL combination products meet FDA, EU MDR, and other global regulatory requirements while adhering to Design Controls.

This role involves collaborating with global teams across the product lifecycle, applying risk management (FMEA), validation/verification, and quality engineering techniques, and supporting audits and process improvements