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Senior Medical Device Quality Engineer

3 months ago

Vandalia, United States 100293 Johnson Medtech LLC Full time

Senior Medical Device Quality Engineer Johnson Electric is excited to announce we are now recruiting for a Sr. Quality Engineer - Medical Devices for an onsite position at our Vandalia, OH facility. We are seeking a highly skilled Quality Engineer with a strong background in FDA regulatory knowledge, statistical process control, and problem-solving abilities. The ideal candidate will be responsible for ensuring that all products are designed and manufactured in accordance with industry and company standards. This candidate will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&R Manager. This position will lead all customer and third-party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements. Your responsibilities will be to: Ensure customer and regulatory requirements are met along the product development cycle. Develop and implement medical quality system per ISO13485 and customer requirements. Create production, calibration, inspection, and maintenance procedures as required. Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failure. Assist and/or complete with the resolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions. Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Develop, review, and improve inspection plans, standard work sheet and product drawings. Work on continuous improvement activities. Support Kaizen activities and re-work/scrap reduction. Develop and implement quality management systems compliant with FDA regulations. Conduct CPK (Process Capability Index) analysis to evaluate process performance and product consistency. Lead root cause analysis and implement corrective actions for product and process issues. Collaborate with cross-functional teams to ensure quality throughout the product lifecycle. Design and execute validation protocols for new processes and equipment. Monitor and report on quality metrics, trends, and performance. Provide training and support to staff on quality assurance processes and FDA compliance. Our requirements: Bachelor’s degree in engineering, Quality Assurance, or related field. 3+ Years Quality Experience within in Medical Device Manufacturing. Extensive knowledge of FDA regulations, including 21 CFR Part 820 AND ISO13485. Proficiency in equipment validation/qualifications (IQ, OQ, PQ). Proficiency in statistical analysis and understanding of CPK and other quality metrics. Strong problem-solving skills using FMEA, FTA methodology. Ability to navigate and perform in cross-functional teams. Excellent communication and interpersonal skills. What We offer: JE offers talented employees exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits. Come join our global, inclusive & diverse team Our purpose is to improve the quality of life of everyone we touch through our innovative motion systems. We are a truly global team bound together by our shared values. Our culture is built on the diversity, knowledge, skills, creativity, and talents that each employee brings to the company. Our people are our company’s most valuable asset. We are committed to providing an inclusive, diverse and equitable workplace where employees of different backgrounds feel valued and respected, regardless of their age, gender, race, ethnicity or religious background. We are committed to inspiring our employees to grow, act with ownership and find fulfillment and meaning in the work they do. About Johnson Electric Group The Johnson Electric Group is a global leader in electric motors, actuators, motion subsystems and related electro-mechanical components. It serves a broad range of industries, including Automotive, Smart Metering, Medical Devices, Business Equipment, Home Automation, Ventilation, White Goods, Power Tools, and Lawn & Garden Equipment. The Group is headquartered in Hong Kong and employs over 35,000 individuals in 22 countries worldwide. Johnson Electric Holdings Limited is listed on The Stock Exchange of Hong Kong Limited (Stock Code: 179). #J-18808-Ljbffr