Quality Engineer

iSono Health is looking for a Quality Engineer to help us drive our quality mission by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve products and processes. Apply here

Job Responsibilities

• Support company product development and design changes activities in compliance with the company's Quality System, focusing on DFX, and assess the reliability of new designs.
• Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer, etc.
• Serve as project management lead with compliance to Design, Process, and Purchasing Controls and Risk Management procedures and delivery of robust Design History Files.
• Support manufacturing and operation activities including performing inspections, production quality assessment, and finished goods fulfillment
• Participate in design impact assessments and supplier quality management
• Plan and create quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices utilizing clinical and engineering knowledge.
• Develop comprehensive procedures, including work instructions, flowcharts, forms, templates, checklists, and other product or process-related documentation, for recording, evaluating, and reporting product and process quality data.
• Perform deep technical failure analysis based on the physics of failure.
• Initiate, investigate, or coordinate CAPAs involving the products and internal or external processes where noncompliance with procedures, regulatory requirements, and industry standards is found.
• Provide support for the internal and external audits as a member of the QA audit team.
• Advocate for exceptional customer experience through product quality, safety, design, reliability, and usability.
• Implement a supplier quality program defining approved vendors, conducting supplier audits, and providing feedback on potential partners.
• Implement and scale manufacturing operations quality processes from early builds through pilot and production (incoming, in-process, final inspection, DHR/traceability, and release criteria).
• Partner with Operations/Manufacturing to stand up production workflows, work instructions, routings, training, and shop-floor controls to ensure consistent, repeatable output.
• Define, track, and report quality/manufacturing KPIs (e.g., yield, scrap, rework, defect rates, FPY, incoming acceptance rates, CAPA cycle time, supplier PPM) and drive corrective actions based on trends.
• Establish a quality cadence for operations (MRB rhythm, daily/weekly quality reviews, escalation paths, and continuous improvement actions) and ensure timely closure of issues.
• Drive supplier and incoming quality execution by implementing IQC plans, supplier scorecards, and clear acceptance criteria aligned to risk and reliability targets.
• Build and scale operational quality systems (IQC/in-process/final controls, NCR/MRB workflows, traceability expectations, and production readiness).
• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or equivalent.
• 5+ years of hands-on experience in the medical device industry.
• Must be obsessed with quality, detail-oriented, well-organized, and have excellent written and oral communication skills.
• Must have experience implementing manufacturing/operations quality processes and driving KPI-based continuous improvement in a regulated medical device environment.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
• Ability to conduct product investigations, write reports and procedure manuals
• Prior experience with audits, NCRs, complaints, pFMEA, and IQC.
• Experience with medical device HW/FW/SW testing (e.g., IEC 60601, IEC 62304).
• Detail-oriented with strong written and verbal communication skills; able to write reports and procedure manuals.
• Must be able to work well with interdisciplinary teams and to project manage cross-functionally
• Ability to conduct product investigations, write reports and procedure manuals
• Able to work effectively with interdisciplinary teams and project manage cross-functionally.
• Strong analytical skills with a track record of diagnosing and fixing complex problems.

Preferred Requirement:

• Deep technical background in electromechanical devices and robotics.
• Experience in design for reliability, manufacturability, and serviceability.
• ASQ CQE, CRE, CSQE, or CQA certification.
• Understanding of software development lifecycle, architecture, and configuration management.
• Proficient with tools such as Jira, Git Hub, GrabCAD, and Arena.
• Strong understanding of statistical methods and process techniques.
• Experience creating FMEAs.
• Experience with database quality and security standards.
• Experience setting up Quality Management Systems and adhering to quality standards.