Sr. Quality Engineer
Enovis Healthcare Solutions
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Benefits offered by this job
Job summary
Enovis seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining engineering programs.
You will ensure products and processes comply with internal quality systems and global regulatory requirements while partnering with cross-functional teams to drive product quality and continuous improvement. You will also lead audits (FDA/ISO/MDSAP), manage risk, and guide CAPA investigations, with a focus on design controls and software as a medical device.
Qualifications
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline.
- 3+ years of Quality Assurance experience within medical device or highly regulated industries.
- Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable regulations.
- Experience leading CAPA investigations, internal audits, risk management activities, and QA improvements.
- Strong understanding of manufacturing processes, process validation, and statistical analysis techniques.
- Excellent technical writing, analytical, and problem-solving skills.
- Strong communication and leadership with cross-functional influence.
- Knowledge and experience with software as a medical device.
- Independently plan, develop, and execute software verification/validation (V&V) strategies aligned with regulatory requirements.
- Review/approve software requirements, design docs, risk management files, and test protocols for traceability and compliance.
- Review/approve detailed test protocols and evidence of test execution per procedures.
Responsibilities
- Serve as senior QA representative for NPD and sustaining projects.
- Lead design/manufacturing reviews to ensure QMS and regulatory compliance.
- Lead risk management activities (DFMEAs/PFMEAs) per ISO 14971.
- Review/approve design control documentation and change controls.
- Provide QA leadership during audits (FDA, ISO 13485, MDSAP).
- Lead CAPA investigations and root cause analyses with verification.
- Drive continuous improvement using Lean/Six Sigma principles.
- Mentor junior QA engineers and cross-functional teams.
- Analyze quality metrics and manufacturing data to identify systemic risks and corrective actions.
- Collaborate with Engineering, Regulatory, Manufacturing, and Ops to ensure product quality.
- Develop, review, maintain quality procedures, work instructions, and validation docs.
- Support supplier quality activities and process validation as required.
Skills
Education
Tools
Job description
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.
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.
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.
Sr. Quality Engineer
Austin, Texas
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Ability to sit or stand for extended periods
- Regular use of computer and office equipment
- 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
- 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.
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.
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