Medical Device Quality Engineer
Enovis Corporation
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Benefits offered by this job
Job summary
Enovis Corporation in Austin, TX is seeking a Medical Device Quality Engineer to support quality assurance activities, ensuring safety, quality and regulatory compliance for medical devices. The role reports to the Sr.
Manager, Quality Engineering and requires collaborating with manufacturing and suppliers on CAPA, MRB and validation activities. The candidate will participate in audits, trend analysis and documentation efforts, with a focus on improving product quality and patient safety within
Qualifications
- Bachelor’s degree in Engineering, Science, or related technical field.
- Knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
- Basic documentation practices and quality best practices.
- Ability to write clear, concise technical documentation.
- Onsite work at Austin manufacturing facility.
Responsibilities
- Ensure compliance with GMP, ISO, FDA, and CMDR requirements.
- Evaluate product quality issues affecting device performance or safety.
- Assist with disposition of nonconforming material via MRB.
- Update quality standards, procedures, and work instructions.
- Support IQ/OQ/PQ validations and related documentation.
- Assist supplier quality activities including SCARs and audits.
- Perform trend analysis on quality data to identify improvements.
- Contribute to root cause investigations and CAPA activities.
- Collaborate with Manufacturing and Operations on quality concerns.
- Assist in audits and closure of findings.
- Support special projects as assigned.
Skills
Education
Tools
Job description
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.
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 support Enovis in helping drive the medical technology industry forward by supporting quality processes, patient safety, and compliance.
Medical Device Quality Engineer
Sr. Manager, Quality Engineering
Austin, TX
As a member of the Quality Assurance team, you will support activities that help Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Utilizing foundational knowledge of engineering and problem-solving principles, this position is responsible for supporting quality assurance activities related to the implementation, maintenance, and improvement of procedures and work instructions to help ensure safety, quality, and compliance with Company standards and government regulations.
- Ensuring compliance with internal and external specifications and standards, including GMP, ISO, FDA, and CMDR requirements.
- Supporting evaluation of product quality issues that may impact device performance, patient safety, or regulatory compliance.
- Supporting the evaluation of nonconforming material and assisting with dispositions through cross-functional engineering review as part of the MRB.
- Supporting updates or changes to quality standards, procedures, and work instructions.
- Assisting with process and equipment validations, including IQ/OQ/PQ documentation.
- Supporting supplier quality activities, including review of incoming nonconformances, supplier corrective actions (SCARs), audits, and supplier performance monitoring.
- Performing trend analysis on production and quality data to identify improvement opportunities.
- Contributing to root cause investigations using structured problem-solving methods.
- Contributing to CAPA activities, including investigation, documentation, and effectiveness verification.
- Partnering with Manufacturing and Operations to help address quality or compliance concerns.
- Participating in internal and external audits, including audit preparation, providing support during audits, and assisting with closure of findings
- Supporting special projects as assigned
- Bachelor’s degree in Engineering, Science, or related technical field and 0–2 years of experience, preferably in medical device manufacturing
- Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
- Basic understanding of good documentation practices, and quality best practices.
- Demonstrated ability to write clear, concise technical documentation.
- Must be able to work 100% onsite at Austin manufacturing facility
- Proficiency in MS Office Suite, including Excel, Word and PowerPoint
- Must be able to lift 50 lbs.
- Must be able to bend, twist, and lift overhead.
- Internship, co-op, or prior experience in manufacturing, quality, engineering, in a regulated industry preferred.
- Exposure to manufacturing equipment transfers and validation activities, including IQ/OQ/PQ, preferred.
- Background or coursework related to Medical Device, Pharmaceuticals, or another regulated industry preferred.
- Basic knowledge of ISO 13485 quality standards preferred.
- Basic familiarity with quality and problem-solving tools (e.g., DMAIC, FMEA, statistical analysis) preferred.
- Basic knowledge of manufacturing processes preferred, including precision machining, finishing, inspection, product cleaning, and sterilization.
- Basic knowledge of Geometric Dimensioning & Tolerancing (GD&T) preferred.
- Preferred exposure to the following software packages: SolidWorks, SolidWorks ePDM, Oracle R12, and Agile PLM.
- CQE, Lean, or Six Sigma exposure or certification preferred, but not required
- 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
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.
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
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.
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