Medical Device Quality Engineer

Enovis•Austin, TX

2d•Onsite

About The Position

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 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.

Requirements

Bachelor’s in Science or Engineering and 3+ years of experience.
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.
Must possess the knowledge, skills and abilities or be able to explain and demonstrate that they can perform the essential functions of the job, with or without reasonable accommodations, using some other combination of skills and abilities.
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

Nice To Haves

Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
Prefer CQE, Lean, or 6 Sigma Certification

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.