Senior Quality Assurance (QA) Engineer

Company Description

Novoxel® has developed Tixel®, a medical device powered by novel thermal technology for fractional skin resurfacing. Tixel is powered by TMA® (Thermo-Mechanical Action), a non-laser fractional treatment technology that can transfer thermal energy to the skin very quickly and safely. The energy is emitted through a matrix of tiny pyramid-shaped pins made of biocompatible materials covering a treatment area of 1cm².

Tixel® employs a hot titanium tip which transfers direct heat to the upper dermis. The proprietary tip is constructed of biocompatible temperature resistant titanium alloy. The tip consists of an array of tiny pyramids which are heated to a temperature of 400°C.

The pins are introduced at precisely controlled speed to the surface of the skin, after which the thermal energy stored in the pins is rapidly transferred to the skin upon brief contact lasting only a few milliseconds. Tixel® offers a new dimension in compactness, ergonomic design and operating comfort to its users

We are seeking a highly experienced Senior QA Engineer to be a key leader in our Quality Management System (QMS). This role is critical for ensuring our medical devices are developed, manufactured, and maintained in strict compliance with ISO 13485:2016, EU MDR (2017/745), and FDA 21 CFR Part 820 (QMSR). The successful candidate will leverage technical expertise, risk management leadership, and a quality-first mindset to drive compliance across the entire product lifecycle.

• QMS Implementation & Maintenance: Lead the continuous improvement of the QMS to meet global standards (ISO 13485, MDR, CFR 820), ensuring the system is audit-ready for Notified Bodies and the FDA.
• Design Assurance (NPD): Act as the QA representative for New Product Development, reviewing and approving Design History Files (DHF) to ensure robust Design Inputs, Outputs, and successful Verification/Validation (V&V).
• Risk Management Leadership: Lead all risk management activities in accordance with ISO 14971. Facilitate and maintain Design and Process FMEAs to ensure all potential hazards are mitigated.
• Change Control Management: Systematically lead the evaluation and approval of all product, process, and document changes. Ensure robust impact assessments on safety, efficacy, and the Risk Management File (ISO 14971). Regulatory assessments to determine if changes require new FDA 510(k) filings or EU MDR Technical Documentation updates.
• CAPA & Non-Conformance (NC) Investigations: Support the Corrective and Preventive Action (CAPA) system. Lead root cause investigations for non-conformances (NCRs) and customer complaints, ensuring effective long-term solutions are implemented.
• Complaint & Vigilance Handling: Oversee the complaint handling process, ensuring timely and uniform processing of all feedback. Lead technical investigations into device failures, determine reportability for Medical Device Reports (MDR) or EU MDR Vigilance (incidents/FSCA), and ensure trend analysis escalates issues to the CAPA system when necessary.
• Process Validation: Oversee and approve validation protocols and reports (IQ/OQ/PQ) for manufacturing equipment, Software and Microbiology testing.  
• Internal Audit Program: Manage and execute the Internal Audit program to verify QMS effectiveness. This includes establishing the annual audit schedule, conducting cross-functional audits, and ensuring all findings are resolved through appropriate CAPA or containment actions.

• Educational Foundation: Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical), Life Sciences, or a related technical field.
• Industry Expertise: A minimum of 5–8 years of direct Quality Assurance experience within the medical device industry, specifically supporting Class II medical devices.
• Proven, hands-on experience implementing and maintaining compliance with ISO 13485:2016, EU MDR (2017/745), and FDA 21 CFR Part 820 (including the 2026 QMSR transition).
• Risk Management Leadership: Expert-level proficiency in ISO 14971, with demonstrated experience leading cross-functional teams through dFMEA and pFMEA sessions.
• Design & Change Control: Extensive experience managing Design History Files (DHF) and executing Change Control processes, including the ability to write robust technical justifications for regulatory impact and "Justifications for Non-Filing."
• Audit Execution: Certified Internal Lead Auditor (ISO 13485\MDR) with a track record of managing annual audit schedules and representing the Quality function during Notified Body audits or FDA inspections.
• Technical Validation: Extensive expertise in V&V (Verification & Validation) frameworks. This includes reviewing and approving Software Test Protocols (STP) and reports (STR), cleaning validation, and manufacturing process validation.
• Investigation & CAPA: Advanced skills in root cause analysis methodologies (e.g., Fishbone, 5 Whys) to resolve complex non-conformances and drive the CAPA process to closure.
• Complaint & Vigilance Proficiency: Demonstrated experience in medical device Complaint Handling, including root cause investigation of field failures and a deep understanding of global reporting timelines (MDR/Vigilance) for adverse events.



📩 Interested in joining our team? Please send your CV to: moran.tsahar@tixelmed.com (Please include "Senior QA Engineer Application" in the subject line)

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