Quality Engineer

Join a quality-focused medical manufacturing environment where you will play a key role in maintaining and improving product quality, regulatory compliance, and quality system effectiveness. This position offers the opportunity to work cross-functionally with engineering, operations, suppliers, and leadership while supporting new product development and continuous improvement initiatives. The Quality Engineer serves as a subject matter expert for quality processes, supplier quality, and regulatory compliance. RESPONSIBILITIES Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory standards. Develop, review, and maintain quality documentation including SOPs, protocols, reports, validation documents, quality plans, and work instructions. Investigate product, process, and supplier-related quality issues and implement effective corrective actions. Coordinate nonconformance activities, Material Review Board (MRB) processes, and CAPA investigations within an electronic quality management system. Analyze quality metrics and trend data to identify risks, improvement opportunities, and compliance concerns. Lead root cause investigations related to complaints, audits, product issues, and manufacturing deviations. Manage complaint records and support complaint investigations, including regulatory reporting assessments when required. Oversee calibration activities to ensure inspection and production equipment remain compliant and properly maintained. Monitor environmental controls and respond to out-of-specification conditions as necessary. Support supplier quality activities including supplier documentation, evaluations, and audits. Maintain device records, quality documentation, and change control processes. Process engineering and document change requests while ensuring proper implementation and compliance. Develop clear process instructions and support employee training initiatives. Partner with cross-functional teams to support product development, manufacturing quality, and continuous improvement efforts. QUALIFICATIONS 5–7 years of experience within a medical device or regulated manufacturing environment preferred. 3–5 years of experience authoring technical documentation compliant with FDA and ISO 13485 requirements. Strong understanding of quality systems, regulatory compliance, risk management, validation, statistical analysis, FMEA, and reliability principles. Experience managing nonconformances, CAPAs, complaint investigations, and root cause analysis. Knowledge of FDA Quality System Regulations, ISO 13485, and related medical device standards. Experience with supplier quality programs and audit support is highly desirable. Strong technical writing, communication, and organizational skills. Proficiency with electronic document management and quality management systems. Ability to manage multiple priorities independently in a fast-paced environment. ASQ certification and experience with quality management software platforms are a plus. Approximately 10% travel may be required. BENEFITS Opportunity to make a direct impact on product quality and patient safety. Exposure to new product development and regulatory compliance initiatives. Collaborative environment with cross-functional interaction and leadership visibility. Professional growth within quality engineering, supplier quality, and regulatory compliance disciplines. Opportunity to work with advanced quality systems, investigations, validation activities, and continuous improvement programs. Comprehensive benefits package, paid time off, and career development opportunities (where applicable). #J-18808-Ljbffr