QA Engineer - Operations

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:

Quality Assurance Engineer - Operations

Reports To:

Sr. Director, Quality

Location:

Houston Plant (onsite)

Business Unit Description:

Foot and Ankle

High-Level Position Summary:

We are seeking a skilled and experienced Quality Assurance Engineer to join our team. The incumbent provides quality support to manufacturing and supply chain. Focus on nonconforming material program, validation program, and cleanroom support.

Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

• 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

• Author and review equipment and process validation protocols and reports (IQ/OQ/PQ)

• Responsible for environmental monitoring and dose audit program for sterile devices packaged in Houston cleanroom environment

• Assuring compliance to internal or external specifications and standards (i.e. GMP, ISO, FDA)

• Reviewing trends in device failures associated with nonconforming materials

• Leading root cause analysis and CAPA investigations

• Supporting 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 3+ years experience

• Background in Medical Device or 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

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 tug, pull, or lift up to twenty-five (25) pounds.

Desired Characteristics:

• Preferred knowledge of inspection equipment and techniques.

• Familiarity with sterile packaging in cleanroom environments.

• Familiarity with Agile PLM.

• 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 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.

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.