Medical Device Quality Engineer

Medical Device Quality EngineerAs a key member of the Quality Team, you will support Enovis in helping drive the medical technology industry forward by supporting quality processes, patient safety, and compliance.Essential Responsibilities:Ensuring compliance with internal and external specifications and standards, including GMP, ISO, FDA, and C MDR requirements.Supporting evaluation of product quality issues that may impact device performance, patient safety, or regulatory compliance.Supporting the evaluation of nonconforming material and assisting with dispositions through cross-functional engineering review as part of the MRB.Supporting updates or changes to quality standards, procedures, and work instructions.Assisting with process and equipment validations, including IQ/OQ/PQ documentation.Supporting supplier quality activities, including review of incoming nonconformances, supplier corrective actions (SCARs), audits, and supplier performance monitoring.Performing trend analysis on production and quality data to identify improvement opportunities.Contributing to root cause investigations using structured problem-solving methods.Contributing to CAPA activities, including investigation, documentation, and effectiveness verification.Partnering with Manufacturing and Operations to help address quality or compliance concerns.Participating in internal and external audits, including audit preparation, providing support during audits, and assisting with closure of findings.Supporting special projects as assigned.Minimum Basic Qualifications:Bachelor's degree in Engineering, Science, or related technical field and 0–2 years of experience, preferably in medical device manufacturing.Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.Basic understanding of good documentation practices, and quality best practices.Demonstrated ability to write clear, concise technical documentation.Must be able to work 100% onsite at Austin manufacturing facility.Proficiency in MS Office Suite, including Excel, Word and PowerPoint.Must be able to lift 50 lbs.Must be able to bend, twist, and lift overhead.Desired Characteristics:Internship, co-op, or prior experience in manufacturing, quality, engineering, in a regulated industry preferred.Exposure to manufacturing equipment transfers and validation activities, including IQ/OQ/PQ, preferred.Background or coursework related to Medical Device, Pharmaceuticals, or another regulated industry preferred.Basic knowledge of ISO 13485 quality standards preferred.Basic familiarity with quality and problem-solving tools (e.g., DMAIC, FMEA, statistical analysis) preferred.Basic knowledge of manufacturing processes preferred, including precision machining, finishing, inspection, product cleaning, and sterilization.Basic knowledge of Geometric Dimensioning & Tolerancing (GD&T) preferred.Preferred exposure to the following software packages: SolidWorks, SolidWorks ePDM, Oracle R12, and Agile PLM.CQE, Lean, or Six Sigma exposure or certification preferred, but not required.Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.Join us in creating better together.EQUAL EMPLOYMENT OPPORTUNITY Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.