Enovis
About Enovis
Enovis Corporation (NYSE: ENOV) is an innovation‑driven medical technology company focused on developing clinically differentiated solutions that improve patient outcomes and transform workflows. With a culture of continuous improvement, global talent, and innovation, Enovis delivers integrated technologies that support active lifestyles in orthopedics and beyond. For more information, visit www.enovis.com.
Quality Assurance Engineer – Operations
This role supports manufacturing and supply chain quality functions, focusing on nonconforming material, validation programs, and cleanroom support.
Key Responsibilities
Evaluate nonconforming material and disposition based on cross‑functional engineering review.
Perform analysis of production data to identify trends.
Initiate, develop, and recommend updates to quality standards and procedures.
Author and review equipment and process validation protocols and reports (IQ/OQ/PQ).
Manage environmental monitoring and dose audit programs for sterile devices in the Houston cleanroom.
Ensure compliance with internal and external specifications (GMP, ISO, FDA).
Review trends in device failures associated with nonconforming materials.
Lead root cause analysis and CAPA investigations.
Support operations in remedying adverse quality or compliance issues.
Minimum Qualifications
Bachelor’s degree in Engineering and 3+ years of experience.
Background in Medical Device or a highly regulated industry.
Knowledge of ISO 13485, ISO 14971, and FDA regulations.
Advanced mechanical inspection expertise and associated equipment.
Basic knowledge of manufacturing processes: metrology, machining, product cleaning, and sterilization.
Proficiency with Microsoft Office Suite.
Work Environment & Physical Demands
Office space is clean, orderly, and well‑lit; noise is low to moderate.
Manufacturing floor presents moderate to high noise and exposure to equipment hazards.
Ability to sit, stand, and sit/stand for long periods.
Ability to lift up to 25 pounds.
Desired Characteristics
Knowledge of inspection equipment and techniques.
Familiarity with sterile packaging in cleanroom environments.
Familiarity with Agile PLM.
Ability to work and multi‑task with minimal supervision.
Strong oral and written communication skills.
Benefits
Medical, Dental, and Vision Insurance
Spending and Savings Accounts
401(k) Plan
Paid Vacation, Sick Leave, and Holidays
Income Protection Plans
Discounted Insurance Rates
Legal Services
Visa Sponsorship Enovis does not provide sponsorship for employment visas (e.g., H‑1B) and will not offer such sponsorship in the future. Applicants must have full‑time work authorization in the United States without requiring sponsorship.
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 value the unique contributions that every employee brings. 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.
EOE AA M/F/VET/Disability Statement EQUAL EMPLOYMENT OPPORTUNITY—All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of any protected class or status.
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Enovis Corporation (NYSE: ENOV) is an innovation‑driven medical technology company focused on developing clinically differentiated solutions that improve patient outcomes and transform workflows. With a culture of continuous improvement, global talent, and innovation, Enovis delivers integrated technologies that support active lifestyles in orthopedics and beyond. For more information, visit www.enovis.com.
Quality Assurance Engineer – Operations
This role supports manufacturing and supply chain quality functions, focusing on nonconforming material, validation programs, and cleanroom support.
Key Responsibilities
Evaluate nonconforming material and disposition based on cross‑functional engineering review.
Perform analysis of production data to identify trends.
Initiate, develop, and recommend updates to quality standards and procedures.
Author and review equipment and process validation protocols and reports (IQ/OQ/PQ).
Manage environmental monitoring and dose audit programs for sterile devices in the Houston cleanroom.
Ensure compliance with internal and external specifications (GMP, ISO, FDA).
Review trends in device failures associated with nonconforming materials.
Lead root cause analysis and CAPA investigations.
Support operations in remedying adverse quality or compliance issues.
Minimum Qualifications
Bachelor’s degree in Engineering and 3+ years of experience.
Background in Medical Device or a highly regulated industry.
Knowledge of ISO 13485, ISO 14971, and FDA regulations.
Advanced mechanical inspection expertise and associated equipment.
Basic knowledge of manufacturing processes: metrology, machining, product cleaning, and sterilization.
Proficiency with Microsoft Office Suite.
Work Environment & Physical Demands
Office space is clean, orderly, and well‑lit; noise is low to moderate.
Manufacturing floor presents moderate to high noise and exposure to equipment hazards.
Ability to sit, stand, and sit/stand for long periods.
Ability to lift up to 25 pounds.
Desired Characteristics
Knowledge of inspection equipment and techniques.
Familiarity with sterile packaging in cleanroom environments.
Familiarity with Agile PLM.
Ability to work and multi‑task with minimal supervision.
Strong oral and written communication skills.
Benefits
Medical, Dental, and Vision Insurance
Spending and Savings Accounts
401(k) Plan
Paid Vacation, Sick Leave, and Holidays
Income Protection Plans
Discounted Insurance Rates
Legal Services
Visa Sponsorship Enovis does not provide sponsorship for employment visas (e.g., H‑1B) and will not offer such sponsorship in the future. Applicants must have full‑time work authorization in the United States without requiring sponsorship.
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 value the unique contributions that every employee brings. 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.
EOE AA M/F/VET/Disability Statement EQUAL EMPLOYMENT OPPORTUNITY—All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of any protected class or status.
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