Product Quality Assurance Engineer

Eko Health•Emeryville, CA

49d•Hybrid

About The Position

The Product Quality Assurance Engineer will lead efforts to ensure Eko's products are designed and developed is in compliance with procedures and industry standards, regulations and best practices. In this role the Product Quality Assurance Engineer will be responsible for following and maintaining our Quality Management System processes to support the development of products in compliance with international and US medical device regulations. This role offers a high degree of autonomy and will work closely with the product development team to drive the completion of key design control, risk management, and change control deliverables for new product development and current on-market products. The role will partner with cross-functional groups to ensure audit-readiness across the quality management system including complaints/feedback, CAPA/NC closures, internal audit planning/execution, and supplier evaluation/approval. The ideal candidate has worked in a medical device industry regulated by ISO 13485 and 21 CFR 820 and includes products containing both hardware and software aspects. This is a hybrid role with required onsite presence on Tue/Wed/Thu.

Requirements

Bachelor's degree in engineering, Quality, Life Sciences, or a related field (or equivalent experience).
5+ years of experience in a Quality Assurance/systems role within a regulated industry.
In-depth knowledge of quality systems, ISO standards (such as ISO 13485), FDA regulations, ICH Quality, CRFs, and other relevant quality frameworks.
Experience in implementing state-of-the-art medical device standards, including ISO 13485 (Quality Management), ISO 14971 (Risk Management), IEC 60601 (Electrical Safety), IEC 62304 (Software Lifecycle), IEC 81001-5-1 (Health Software Cybersecurity), ISO 14155 (Clinical Investigation of Medical Devices), and compliance with 21 CFR 820 and EU MDR, with a strong focus on design controls, risk management, and systems engineering integration

Nice To Haves

Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV (such as, GMP, GAMP, Part 11, Annex 11, ICH Q9, etc.) activities and compliance.
In-depth knowledge of relevant CFR (Title 21), Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines including thorough knowledge of appropriate GCP, GLP, and GMP policies and procedures.

Responsibilities

Support the new product development and sustaining engineering functions to ensure products are designed, developed and maintained, ensuring compliance with industry regulations and internal standards.
Acts as the QA point of contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned products/systems.
Writes and/or reviews and approves validation documents. This includes, but may not be limited to, Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, applicable Test Scripts or other documents as may be appropriate.
Performs GxP-related activities in alignment with business requirements and ensures that they meet compliance standards as defined by the applicable regulations.
Maintain an up-to-date knowledge of industry standards, regulations, and best practices related to quality management, and implement changes as necessary.
Facilitate development and maintenance of product design documents including as applicable design inputs, product requirements specification, design output documents, DMR, DHF, and design traceability matrices.
Support risk management activities to maintain a comprehensive product risk management file including product hazard analysis/FMEA, use error analysis and risk management report.
Lead product specific quality system activities and processes per ISO 13485, including complaint handling and CAPA investigation, and supplier evaluations, training development and management, etc. to ensure product quality and proper implementation of compliant processes.
Collaborate with internal teams to identify and implement improvements to quality management processes and ensure internal SOPs are compliant with applicable international and local regulations.