Serve as the Quality Engineering representative for assigned structural heart valve products, supporting design controls, risk management, design verification/validation, design transfer, DHF/DMR content, and product/process changes.
Apply knowledge of structural heart implant expectations, including the ISO 5840 series, to support product requirements, verification/validation strategies, and objective evidence.
Support liquid chemical sterilization activities for products that may contain animal-derived tissue, including validation, routine monitoring, deviations, requalification, and release support; maintain working knowledge of ISO 14160, ISO 22442, ISO 11135, and other relevant sterilization standards.
Support sterilization-related microbiology test methods and data review, including bioburden, sterility, bacterial endotoxin/BET-LAL, microbial identification, method suitability, excursions, and trending; provide trained backup support to the in-house microbiologist for defined routine activities as needed.
Assist Operations and Manufacturing Engineering in establishing acceptance activities, including incoming, in-process, and final inspection/test requirements, sampling plans, acceptance criteria, inspection methods, test method validation needs, fixtures, and quality records.
Support cleanroom and controlled manufacturing operations, including issue triage, process validation/qualification review, line readiness, DHR review, finished goods release, and lot/batch disposition.
Lead or support NCR, MRB, CAPA, audit, and continuous improvement activities, including root cause analysis, risk-based disposition, effectiveness verification, and quality data trending.
Create, review, and improve SOPs, work instructions, forms, templates, and quality records related to product quality, sterilization, microbiology testing, acceptance activities, DHR review, and manufacturing quality processes.