Global Medical Device & Packaging QA Engineer

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

Job summary

CSL Vifor in Massachusetts seeks a seasoned Quality for Combination Products and Medical Devices professional to drive design, development, manufacture and regulatory approval of combination products. This role ensures 21 CFR Part 4 compliant quality systems, guides design controls, risk management and audits, and collaborates with global teams to deliver compliant, safe medical devices.

Ideal candidates have 5+ years in medical device/CPQ quality, strong communication, problem-solving, and a

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.
• Knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR and related QMS standards.
• Experience with drug-delivery combination products is strongly preferred.

Responsibilities

• Serve as Medical Device and Packaging QA on assigned projects ensuring design work meets FDA/EU MDR requirements.
• Ensure external partners meet CSL standards; participate in audits and review agreements.
• Provide regular progress reports and flag quality/system risks.
• Develop and implement a quality system compliant with 21 CFR Part 4 and MDR; update SOPs/WIs.
• Stay current with regulatory changes for medical devices and combination products.
• Maintain systems/databases (Standards List, vendor certs, test method validation log).
• Conduct root cause analysis and recommend corrective actions.

Skills

FDA regulations

Design Controls

Risk Management (FMEA)

Root Cause Analysis

Quality System Mgmt

Vendor Audits

Communication Skills

Problem Solving

Project Planning

Embedded software/connected health

Education

Bachelor’s degree in mechanical or biomedical engineering

Job description

CSL Vifor in Massachusetts seeks a seasoned Quality for Combination Products and Medical Devices professional to drive design, development, manufacture and regulatory approval of combination products. This role ensures 21 CFR Part 4 compliant quality systems, guides design controls, risk management and audits, and collaborates with global teams to deliver compliant, safe medical devices.

Ideal candidates have 5+ years in medical device/CPQ quality, strong communication, problem-solving, and a