Senior Medical Device & Packaging Quality Engineer

CSL; Waltham (MA); Hybrid; USD 115.000 - 136.000; Vollzeit

Zusammenfassung

CSL Behring is seeking a Quality Associate for Combination Products and Medical Devices (CP/MD QA) to represent Quality across global design, development, manufacturing, and regulatory activities. You will ensure adherence to 21 CFR Part 4, ISO standards, and MDR, guiding design controls and risk analyses throughout product lifecycle.

The role collaborates with internal and external teams, provides progress updates, and supports improvements to the quality system while keeping pace with evolving

Qualifikationen

• Bachelor’s degree in mechanical or biomedical engineering or life sciences.
• Minimum 5 years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Experience with 21 CFR Part 4, MDR and ISO standards is desirable.

Aufgaben

• Represent Quality in global teams for CSL combination products; ensure design development meets regulatory requirements.
• Ensure external medical device development and manufacturing partners meet CSL standards; participate in audits and review quality agreements.
• Provide regular progress reports and escalate risks to Quality management and stakeholders.
• Develop and implement a quality system compliant with 21 CFR Part 4 and MDR; update SOPs/WIs/Forms; conduct training.
• Stay updated on regulatory changes for medical devices and combination products.
• Maintain systems/databases such as standards lists, vendor certificates, and test method validation logs.
• Conduct root cause analysis and problem solving with recommendations.

Kenntnisse

Regulatory knowledge

Quality engineering

Risk analysis

Design controls

Root cause analysis

Vendor management

Auditing

Cross-functional collaboration

Ausbildung

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

Jobbeschreibung

CSL Behring is seeking a Quality Associate for Combination Products and Medical Devices (CP/MD QA) to represent Quality across global design, development, manufacturing, and regulatory activities. You will ensure adherence to 21 CFR Part 4, ISO standards, and MDR, guiding design controls and risk analyses throughout product lifecycle.

The role collaborates with internal and external teams, provides progress updates, and supports improvements to the quality system while keeping pace with evolving