Sr. Quality Engineer

## Principal Quality Engineer Apply locations:
USA, Texas, Austin time type:
Full time posted on:
Posted Todayjob requisition :
R0033776##
** Who We Are
**** ABOUT ENOVISTM
** 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
** What You'll Do
** At EnovisTM 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.
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* Job Title:

** Principal Quality Engineer
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* Location:

** Austin, Texas
** Job Title/High Level Position Summary**:
* The Principal 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 Responsibilitie
**** s
* ** 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.
* 5+ 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…