Qa Engineer - Medical Products

Position: QA ENGINEER - MEDICAL PRODUCTS
# QA ENGINEER - MEDICAL PRODUCTS Franklin, KY - Franklin, KY 42134## Overview Level Experienced Position  Type Full Time Category Quality ## Description
** Job Summary
** The Quality Assurance Engineer supports the quality, safety, and regulatory compliance of Vybond’s medical‐related products. This role is dedicated exclusively to medical device and medical‐use product lines, ensuring they meet all applicable FDA, ISO, and customer requirements. The position strengthens a culture of continuous improvement, cross‐functional collaboration, and disciplined quality practices. The ideal candidate is analytical, detail‐oriented, and committed to advancing quality performance in a regulated manufacturing environment.
** Key Responsibilities
** 1.
** Quality Management System & Regulatory Compliance
*** Maintain and improve the Vybond QMS for medical products in alignment with ISO 9001:2015, ISO 13485, and FDA QSR.
* Create, revise, and review SOPs, Work Instructions, and Form Control Documents supporting medical product quality processes.
* Participate in and support internal audits to ensure readiness for external audits and regulatory inspections.
* Maintain compliant Device Master Records (DMR) and Device History Records (DHR) for all medical products.
* Serve as Recall Coordinator, leading mock and official recall activities for medical product lines.
* Ensure full compliance with cGMP, labeling requirements, and all applicable medical device regulations.
2.
** Risk Management & Continuous Improvement*
* * Lead and support risk management activities using FMEA and other risk‐reduction tools.
* Participate in root cause analysis, Kaizen events, and structured problem‐solving initiatives focused on medical product quality.
* Promote a culture of continuous improvement, operational excellence, and regulatory discipline.
3.
** Product & Process Quality for Medical Products
*** Prepare and analyze SPC charts for medical products and process parameters.
* Generate and submit PPAP, IQ/OQ/PQ, and other validation or customer-required documentation for new or modified medical products.
* Review and validate management of change documentation prior to commercialization of new or updated medical products.
* Maintain and execute Test Method Validation (TMV) to ensure repeatability and reproducibility of medical product test methods.
* Conduct Gage R&R and inter-laboratory comparison studies and provide data-driven insights.
* Spend approximately 40% of work time performing routine inspection and verification activities on the manufacturing floor.
4.
** Customer Feedback & Complaint Management
*** Maintain customer feedback and complaint records in accordance with ISO 13485, ISO 9001, and FDA requirements.
* Lead weekly medical product complaint review meetings, ensuring timely follow-up and closure of actions.
* Provide analysis and documentation related to Return Material Authorizations (RMA) for medical products.
5.
** Training & Personnel Development
*** Collaborate with leadership to develop and maintain training curricula specific to medical product quality requirements.
* Partner with cross-functional supervisors to administer competency evaluations and training renewals.
* Ensure training compliance for new or revised SOPs related to medical product quality.
* Support adherence to company policies, principles, and guidelines.
** Other Responsibilities
** 1. Perform additional duties as needed to support medical product quality and regulatory compliance.
2. Rigorously follow and enforce all safety rules and regulations.## Qualifications
** Qualifications
* * 1. Bachelor’s degree in Engineering, Applied Mathematics (with statistics), or a related technical field; or 10 years of relevant experience in lieu of degree.
2. 2–5 years of quality engineering experience in the medical device or medical products industry.
3. Proficiency with Minitab, Excel, Access, PowerPoint, and Word.
4. Strong knowledge of FDA QSR, ISO 13485, and ISO 9001.5. Hands-on experience with TMV, CAPA, and nonconformance management.
6. Strong analytical, communication, and leadership skills with the ability to influence cross-functional teams.
#J-18808-Ljbffr