Medical Device Quality Assurance Engineer

Encore Medical LP; Austin (TX); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis Corporation in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Engineering team. You will evaluate nonconforming material, analyze production data, and lead validations, ensuring compliance with GMP, ISO, and FDA standards.

The role focuses on root cause analysis, CAPA investigations, and collaboration with Manufacturing to address quality issues. A BS in engineering with 3–5 years in regulated industries is required.

Qualifications

• BS in Science or Engineering and 3–5 years of experience in regulated industries.
• Background in Medical Device, Aeronautics, Automotive or similar; ISO 13485 knowledge preferred.
• Strong technical writing and quality documentation practices.
• Basic knowledge of manufacturing processes: metrology, precision machining, grinding, cleaning, sterilization.
• Experience with GMP/ISO/FDA compliance and QA software tools is a plus.

Responsibilities

• Evaluating nonconforming material and dispositioning via cross-functional review.
• Analyzing reports and production data to identify trends.
• Developing updates to quality standards and procedures.
• Authoring and conducting process and equipment validations.
• Ensuring compliance with GMP, ISO, FDA, and CMDR.
• Reviewing device failure trends and leading root cause analyses.
• Leading CAPA investigations and supporting remediation with Manufacturing.

Skills

CQE/Lean/6Sigma

English communication

MS Office proficiency

Education

Bachelor’s 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.

Position Details

Job Title: Medical Device Quality Engineer
Reports To: Sr Manager, Quality Engineering
Location: Austin, Texas

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.

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

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.

Benefits

• 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

Visa and Sponsorship

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.

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.