Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements.
Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control deficiencies for sustaining products.
Supports remediation planning by helping define scope, assumptions, and acceptance criteria for use of legacy evidence; identifies when additional documentation, review, or testing may be needed and escalates to the remediation lead.
Assists with creating and/or updating DHF content as applicable (e.g., design inputs/outputs, design review documentation, verification/validation evidence mapping, and traceability matrices) in accordance with internal procedures and regulatory requirements.
Leads analysis and proactive upkeep of product risk management tools such as Hazard Analysis and DFMEA, including alignment of risk controls to remediated DHF documentation (inputs/outputs, verification, validation, labeling, and post-market information as applicable).
Supports end-to-end traceability by helping reconcile relationships between design inputs, design outputs, risk controls, verification, and validation; documents discrepancies and supports closure of traceability gaps.
Coordinates with cross-functional partners (e.g., R&D, Manufacturing, RA, Document Control) to route DHF remediation updates for review/approval and ensure documentation is completed, version-controlled, and available within required quality systems.
Supports inspection/audit readiness for remediated DHFs by helping organize objective evidence, preparing summaries of remediation decisions/rationale, and assisting in responses to auditor questions under the direction of the remediation lead.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including documentation and compliance gaps identified during DHF remediation.
Supports remediation execution by maintaining assigned trackers/records (e.g., gap lists, action items, evidence inventories) and proactively communicating status, risks, and roadblocks to the remediation lead and functional stakeholders.
Education/Experience:
At least 3 years experience in the medical device industry
Functional understanding of design controls including experience developing, updating, and maintaining product Design History Files and Design Input / Output documentations (Product Specification, Component Specifications, and Prints)
Functional understanding of risk controls including experience with updating and maintaining risk management documentation: DFMEA and Hazard Analysis
