Sr Quality Engineer
Core
Act as a Quality Engineering representative to ensure development and lifecycle management of combination products align with global regulations and standards.
Role type
Senior Quality Engineer (Medical Devices/Combination Products)
Builds
Combination products including vials, prefilled syringes, needle protection systems, pen injectors, and electromechanical on-body injector systems.
Domain
Biotechnology / Pharmaceutical / Medical Devices
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality oversight, Design Control, Change Control, NC/CAPA, Risk Management, Human Factors Engineering, Regulatory Submissions, Audit Support, Continuous Improvement, Design Review, Test Method Validation
Preferred skills
Biotech/pharmaceutical manufacturing experience, Mechanical engineering knowledge, Combination product launch experience, QMS management, Manufacturing/testing process understanding
Technologies
ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210, 211
Responsibilities
Provide quality oversight for combination and non-combination products, review HFE protocols and audit suppliers, train partners on regulations, contribute to regulatory submissions, lead continuous improvements in quality processes, provide independent design reviews, oversee test method qualification and validation.
Seniority
Senior, hands-on IC
