Medical Device Quality Assurance Engineer

Enovis; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Job summary

Enovis in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Assurance team. You will shape QA procedures, validate processes, and ensure compliance with GMP/ISO standards, supporting manufacturing and serving on the Material Review Board.

The ideal candidate holds a science or engineering degree with 3–5 years in regulated environments, with hands-on experience in IQ/OQ/PQ, metrology and device quality issues, and proficiency in SolidWorks and ERP tools.

Qualifications

• Bachelor's degree in Science or Engineering and 3–5 years of experience.
• Experience with manufacturing transfers and IQ/OQ/PQ validation in a regulated environment.
• Background in Medical Device or other highly regulated industries; ISO 13485 knowledge preferred.
• Proficient in technical writing and MS Office.
• Understanding of manufacturing processes: metrology, precision machining, grinding, cleaning, and sterilization.

Responsibilities

• Maintaining and improving quality assurance procedures and work instructions to ensure safety, quality and compliance.
• Support Operations/Manufacturing; QA representative on the Material Review Board.
• Lead root cause analysis and CAPA investigations.
• Perform process and equipment validations.
• Review trends in device failures and customer complaints.
• Assist in implementing quality standards and changes.

Skills

Quality engineering

Technical writing

MS Office

Lean Six Sigma

Education

Bachelor's degree in Science or Engineering

Tools

SolidWorks

SolidWorks ePDM

Oracle R12

Agile PLM

Job description

Who We Are

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

Medical Device Quality Engineer

Reports To

Sr Manager, Quality Engineering

Location

Austin, Texas

Business Unit Description

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/High-Level Position 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.

Key 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.

Minimum Basic Qualifications

• 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

Desired Characteristics

• 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

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.

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

Join us in creating better together.

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.