Medical Device Quality Assurance Engineer

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

Job Title:

Medical Device Quality Engineer

Reports To:

Sr Manager, Quality Engineering

Location:

Austin, Texas

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.

• 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.

• Bachelor’s in Science or Engineering 3-5 years of experience.
• 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

• 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.
• Computer skills (Excel, Word, Power Point).
• Must be able to communicate in English clearly and fluently, in both written and verbal skills

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.

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services