#R0029437
We are seeking a skilled and experienced Quality Assurance Engineer to join our team. The QE - Inspection and Sustaining provides quality support to quality control and reviews product changes to commercialized devices. Focus on inspection reduction initiatives while managing risk and ensuring high product quality
Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
Review inspection strategies and inspection techniques used by Enovis on implant and instrument product
Write inspection plans, CMM programs, and vision system programs
Partner with suppliers to develop their inspection to an extent that they are certified to perform the final inspection in lieu of Enovis
Author and review protocols and reports related to design changes and supplier transfers
Conduct process capability PQs to reduce inspection
Investigate customer complaints
Support Manufacturing and Operations to remedy adverse quality or compliance situations
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.
Minimum Basic Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Bachelor's in Engineering and 5+ years of experience
Background in Medical Device of other highly regulated industry
Knowledge of ISO 13485, ISO 14971, and FDA regulations
Advanced knowledge of mechanical inspection and associated inspection equipment
Requires basic knowledge of manufacturing processes: metrology, machining, product cleaning, and sterilization
Individual should have knowledge of Microsoft Office Suite
Travel up to 10% as needed
Work environment | Physical demands:
The office space is clean, orderly, and properly lighted and ventilated. Noise levels are considered low to moderate.
The manufacturing floor provides direct exposure to manufacturing equipment and hazards. Noise levels are considered moderate to high.
Ability to sit and stand for long periods of time.
Ability to lift and carry 25 pounds.
Ability to tug, pull, or lift up to twenty-five (25) pounds.
Desired Characteristics:
Preferred knowledge of CMM programming in PC-DMIS
Familiarity with vision system programming
Prefer CQE, Lean, or 6 Sigma Certification
Ability to work and multi-task with little supervision
Ability to articulate clearly, professional oral and written communication skills
"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
What does creating better together mean to us at Enovis? Discover the "why" behind our purpose, values and behaviors:
Our Enovis Purpose, Values and Behaviors on Vimeo
We offer a comprehensive benefits package that includes:
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
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. Visit https://www.enovis.com to learn more.
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.
Join us in creating better together.
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 https://www.enovis.com.
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.