NPI Quality Engineer

DJO Global; Atlanta (GA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading medical technology company in Atlanta seeks a NPI Quality Engineer to enhance product quality and compliance. The role involves collaborating on new product development, ensuring adherence to quality standards, and conducting audits. Ideal candidates will have a strong engineering background and experience in regulated industries, particularly medical devices.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Qualifications

• 3+ years of experience in a regulated industry.
• Knowledge of manufacturing processes including metrology and sterilization.

Responsibilities

• Participating in design and manufacturing reviews.
• Conducting internal audits of the quality system.
• Leading corrective and preventive actions.

Skills

Detail oriented

Analytical

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Tools

Solidworks

MiniTab

Netsuite

Agile PLM

Job description

Job Description:

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 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:
NPI Quality Engineer

Reports To:
Sr. NPI Quality Manager

Location:
Atlanta, GA

Business Unit Description:
Foot & Ankle

Job Title/High-Level Position Summary:

• Utilizing a 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 primarily supports New Product Development, Sustaining Product Development, and Complaint Investigations and serves as the QA representative on various PD initiatives.

Key Responsibilities:

• Participating in design and manufacturing reviews
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions
• Develop inspection strategy and methods to support the development and launch of new products.
• Reviewing and approving design and development documentation
• Serve as subject matter expert for design quality in ISO and FDA audits
• Authoring procedures and work instructions that define and govern the quality system
• Conduct internal audits of the quality system and other business functions
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review
• Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)
• Reviewing trends in device failures associated with customer complaints and nonconforming material
• Leading and owning corrective and preventive actions and complaint investigations
• Working on complex special projects as assigned

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:

• Bachelor's degree in Biomedical or Mechanical Engineering and 3+ years of experience (or equivalent combination of education and years of experience).

• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO13485 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.

Travel Requirements:

• Up to 20%

Desired Characteristics:

• Advanced knowledge of ISO 14971 and risk management principles
• Experience with Class II/III Medical Devices
• Preferred knowledge of the following: Solidworks, Solidworks ePDM, MiniTab, Netsuite, Agile PLM, CMM and/or automated inspection system programming.
• Prefer CQE, Lean, or 6 Sigma Certification.
• Detail oriented and analytical

"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.

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.

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.