Sr. Manager, Quality Engineering
EnovisAbout the role
Who We Are
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 sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.
As a key member of the Quality Assurance team, 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. Manager, Quality Engineering
Reports To:
Sr Director, Quality Assurance
Location:
Austin, TX
Business Unit Description:
Recon, Quality
High Level Position Summary:
The Quality Engineering Sr. Manager is responsible for leading a team of quality engineers in driving products and process excellence across the surgical device portfolio. This role ensures compliance with regulatory standards, supports manufacturing as well as new product introduction and fosters a culture of continuous improvement. The Quality Engineering Sr. Manager will collaborate cross-functionally to implement quality strategies that enhance product reliability, reduce risk, and improve operational efficiency.
Key Responsibilities:
- Lead and mentor a team of quality engineers, providing technical guidance and performance management.
- Develop and implement quality strategies that align with business objectives and regulatory requirements.
- Lead quality engineering support for manufacturing operations, ensuring robust process controls, effective risk management, and validation of production methods.
- Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.
- Drive root cause analysis and corrective/preventive actions (CAPA) for product and process issues.
- Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges and improve processes.
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