Quality Engineer

Company: Rhythmlink

Rhythmlink International, LLC, headquartered in Columbia, South Carolina, is a leading designer and manufacturer of single-use neurodiagnostic devices that connect patients to critical monitoring equipment. Founded in 2002 by neurodiagnostic technologists and engineers, the company specializes in products for EEG, EMG, and intraoperative neuromonitoring, offering innovative solutions like MR Conditional/CT-compatible electrodes and the BrainHealth Headset for rapid EEG deployment in critical care settings . Rhythmlink also provides custom packaging, private labeling, and contract manufacturing services, ensuring tailored solutions for diverse medical needs.

Why You Should Join Us

As a Quality Engineer, you will support Rhythmlink product portfolios for our global market. You will be responsible for enabling global product sales by maintaining registration status throughout product lifecycles, advocating for relevant functions of the Quality Management System (QMS), and executing activities related to supplier qualification, evaluation, and performance. You will liaise with internal and external customers and establish strong relationships with Rhythmlink suppliers, customers, and personnel. **Candidates must be based in or willing to relocate to the Columbia, SC area.

What You'll Do

As an Quality Engineer, you will:

Risk Analysis:

Oversee the Risk Management Process per ISO 14971 through review and approval of risk management files for new product development and construction/ maintenance of the Risk Management Files for post commercialization products, including acquisitions. Application of quality concepts and quality tools such as cause and effect diagrams, flowcharts, Pareto charts, and Root Cause Analysis (RCA) principles. Review and approve design control, manufacturing, quality, engineering, and validation/ qualification documents for conformance to departmental procedures and risk management. Review product labels/labeling, ensuring technical accuracy, alignment with the risk profile of the device, and compliance to US and international regulatory requirements and standards. QMS Maintenance: Review sterilization records including monitoring records, acceptance activity records, and sterilization certifications as verification of operational and performance parameters. Review ECO's and collaborate with personnel to assess and manage changes that could negatively impact quality risk levels. Ensure implementation and rigor of product development processes and design control procedures in compliance with the QMS by actively participating in cross-functional formal design reviews and design transfer. Support the Preventative Maintenance and Calibration Program at Rhythmlink, including managing the master validation plan for products and software. Remediation and/or maintenance of technical documentation to state of the art, where required. Analyze quality data and provide compliant, pragmatic guidance to support regulatory compliance activities including responses to agency requests for information and analyses to support quality KPI's and improvement projects. Participate in internal or external audits or regulatory inspections across global sites. Conduct projects and assignments with technical responsibility. Process Specifications/Validations: Maintain process specifications and validation of sterilization processes by contract sterilizers. Maintain supporting sterilization processes including periodic reviews, validations, and necessary product testing. Support software validations, software maintenance, and re-qualifications. Develop product specifications, inspection plans, and test methods to align with current procedural requirements, and contract manufacturing requirements including ANSI sampling methodology. Develop laboratory test procedures and perform and/or oversee test method validation and execution of testing. CAPA / NC: Escalate opportunities for Corrective and Preventive action, assist with investigation/resolution, and confirm effectiveness when required. Manage quality complaint investigations and resolve CAPAs identified in areas of responsibility. Manage technical sample review for complaint samples and non-conforming samples. Supplier Quality: Support supplier quality program, including but not limited to performing supplier validation, verification, qualifications, and monitoring. Represent the organization as primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. Problem-solving of technical issues related to design, development, and manufacturing supporting complaints, CAPA, and SCAR investigations. Develop and manage qualifications of specific products by new or existing suppliers. What You'll Need Bachelor's degree required; Engineering preferred Prior experience in the medical device industry Knowledge of ISO 13485 and 21 CFR 820 Strong analytical, problem-solving, and technical writing skills Familiarity with terminal sterilization methods (EO, Gamma, or E-Beam) and validation processes Perks of the Job

Compensation: DOE

Other Benefits: Medical - BCBS HSA Dental - Guardian Vision - Guardian ST & LT Disability - Unum Life Insurance - Unum Simple IRA - American Funds (3% match) Supplemental - Colonial Life PTO - 3-4 weeks (based on candidate) Corporate holidays - 9 + 1 floating holiday