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 Assurance, 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:
Sr. Quality Engineer
Location:
Austin, Texas
Job Title/High Level Position Summary:
The Sr. Quality Engineer provides technical leadership for quality assurance activities across new product development and sustaining engineering programs. This role ensures products and processes comply with internal quality systems, global regulatory requirements, and industry standards while partnering with cross-functional teams to drive product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.
Key Responsibilities
Serve as the senior Quality Assurance representative for new product development and sustaining engineering projects.
Lead design and manufacturing reviews to ensure compliance with Quality Management System (QMS) requirements and applicable regulatory standards.
Lead risk management activities, including development and review of DFMEAs, PFMEAs, and risk management documentation in accordance with ISO 14971.
Review and approve design control documentation, including design inputs, design outputs, verification and validation protocols, reports, and engineering changes.
Provide technical leadership during internal, external, customer, and regulatory audits, including FDA, ISO 13485, and MDSAP inspections.
Lead complex CAPA investigations, root cause analyses, and effectiveness verification activities.
Drive continuous improvement initiatives using Lean, Six Sigma, and quality engineering principles.
Mentor and provide technical guidance to junior QA Engineers and cross-functional project teams.
Evaluate quality metrics, complaint trends, nonconforming material, and manufacturing data to identify systemic risks and recommend corrective actions.
Partner with Engineering, Manufacturing, Regulatory Affairs, Clinical Affairs, and Operations to ensure product quality throughout the development lifecycle.
Develop, review, and maintain quality procedures, work instructions, validation documentation, and quality records.
Support supplier quality activities, qualification efforts, and process validation as required.
Qualifications & Experience
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline.
3+ years of Quality Assurance experience within the medical device industry or another highly regulated industry.
Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and applicable international regulations.
Demonstrated experience supporting new product development using Design Controls.
Experience leading CAPA investigations, internal audits, risk management activities, and quality system improvements.
Strong understanding of manufacturing processes, process validation, and statistical analysis techniques.
Excellent technical writing, analytical, and problem-solving skills.
Strong communication and leadership skills with the ability to influence cross-functional teams.
Knowledge and experience with software as a medical device.
Independently plan, develop, maintain, and execute comprehensive software verification and validation (V&V) strategies aligned with regulatory and quality requirements.
Review and approve software requirements, design documentation, risk management files, and test protocols to ensure completeness, traceability, and compliance.
Review and approve detailed test protocols and document objective evidence of test execution consistent with internal procedures and regulatory standards.
Perform complex testing activities involving multi-system integrations, data interfaces, interoperability, and performance evaluation.
Preferred Qualifications
ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt/Black Belt, or equivalent certification.
Experience supporting FDA inspections, ISO 13485 certification audits, and MDSAP audits.
Experience with Design Controls, Process Validation (IQ/OQ/PQ), and software validation.
Familiarity with PLM and ERP systems such as Agile PLM, Oracle, SAP, or Windchill.
Experience leading global quality improvement initiatives.
Knowledge of statistical process control (SPC), validation, and reliability engineering.
Skills & Attributes
Demonstrated leadership in Quality Engineering and regulatory compliance.
Expert knowledge of Quality Management Systems and medical device regulations.
Strong risk assessment and problem-solving capabilities.
Excellent mentoring and coaching skills.
Ability to influence technical decisions across multiple functional groups.
Strong project management and organizational skills.
Excellent written and verbal communication skills.
High attention to detail with a commitment to product quality, patient safety, and continuous improvement.
Technical leadership and mentoring.
Ownership of complex quality initiatives.
Audit leadership and regulatory expertise.
Cross-functional influence.
Strategic quality system improvements.
Decision-making authority on quality and compliance matters.
Working Conditions
Office-based environment with clean, organized, and well-lit workspace
Low to moderate noise levels
Primarily computer-based work with cross-functional team interaction
Occasional standing or extended desk work as required
Physical Requirements
Ability to sit or stand for extended periods
Regular use of computer and office equipment
Who We're Looking For:
Quality Leader – passionate about ensuring safe and compliant medical devices
Detail-Oriented Professional – committed to precision in documentation and analysis
Collaborative Influencer – able to guide cross-functional teams toward quality outcomes
Analytical Thinker – skilled in identifying trends and solving complex problems
Audit-Ready Mindset – comfortable operating in highly regulated environments
Continuous Improver – focused on strengthening systems, processes, and outcomes
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.
Skills Required
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical discipline.
- At least 3 years of Quality Assurance experience in the medical device industry or another highly regulated industry.
- Strong knowledge of FDA Quality System Regulation 21 CFR Part 820.
- Strong knowledge of ISO 13485, ISO 14971, and applicable international regulations.
- Experience supporting new product development using Design Controls.
- Experience leading CAPA investigations, internal audits, risk management activities, and quality system improvements.
- Strong understanding of manufacturing processes, process validation, and statistical analysis techniques.
- Knowledge and experience with software as a medical device.
- Ability to plan, develop, maintain, and execute software verification and validation strategies aligned with regulatory and quality requirements.
- Experience reviewing software requirements, design documentation, risk management files, test protocols, traceability, and objective evidence of test execution.
- Experience performing complex testing involving multi-system integrations, data interfaces, interoperability, and performance evaluation.
- Excellent technical writing, analytical, problem-solving, communication, and leadership skills.
- ASQ Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt, or equivalent certification.
- Experience supporting FDA inspections, ISO 13485 certification audits, and MDSAP audits.
- Experience with Design Controls, IQ/OQ/PQ process validation, and software validation.
- Familiarity with Agile PLM, Oracle, SAP, or Windchill.
- Experience leading global quality improvement initiatives.
- Knowledge of statistical process control, validation, and reliability engineering.
Enovis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Enovis and has not been reviewed or approved by Enovis.
-
Healthcare Strength — Healthcare coverage is positioned as comprehensive, with multiple medical, dental, and vision plan options plus HSA/FSA accounts. Income protection offerings are also described as robust, including life, AD&D, and short- and long-term disability coverage.
-
Retirement Support — Retirement benefits include access to a 401(k) plan with an employer match described as competitive. This adds to the overall total-rewards value even where cash compensation sentiment is uneven.
-
Leave & Time Off Breadth — Time-off provisions are described as ample, including vacation, sick leave, and holidays. Paid parental and family leave is also offered, with a stated maximum of six weeks for eligible employees after birth or adoption.
Enovis Insights
What We Do
We are a medical technology company focused on developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, extraordinary talent and innovation, we ‘create better together’ by partnering with healthcare professionals. Our extensive range of products, services and integrated technologies fuel active lifestyles.
