Medical Device Supplier Quality Engineer at Enovis in Austin, TX

Job description

Who We Are ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com . What You'll Do At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself . As a key member of the Quality Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Job Title: Medical Device Supplier Quality Engineer Reports To: Sr Manager, Quality Engineering Location: Austin, Texas Business Unit Description: As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Job Title/High-Level Position Summary Utilizing comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations. This position directly supports Operations/Manufacturing and serves as the QA representative on the Material Review Board. Key Responsibilities: Evaluating Nonconforming material and dispositioning based on cross-functional engineering review Performing analysis of reports and production data to identify trends. Initiating, developing and recommending updates or changes to quality standards and procedures. Authoring and conducting process and equipment validations Assuring compliance to internal or external specifications and standards (i.e. GMP, ISO, FDA, CMDR). Reviewing trends in device failures associated with customer complaints and nonconforming materials. Leading root cause analysis. Leading in corrective and preventive action investigations. Support Manufacturing and Operations to remedy adverse quality or compliance situations. Working on complex special projects as assigned. Minimum Basic Qualifications: Bachelor’s in Science or Engineering with 3-5 years of experience OR 10-12 years of directly-related experience in a quality role . . Experience with manufacturing transfers and validation (IQ/OQ/PQ) in a regulated environment required. Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 13485 quality standards. Knowledge of technical writing quality and best practices. Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization. Individual should have knowledge of Microsoft Office Suite of software or equivalent. Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM. Prefer CQE, Lean, or 6 Sigma Certification Desired Characteristics: Accurate and professional telephone communication Accurate and professional written communication (email, text and formal letter) Position is office based (Austin, TX) Must be able to lift 50 lbs. Must be able to bend, twist and lift overhead. Must possess professional ethics and demeanor Must demonstrate excellent customer service. Compute