Principal Quality Engineer

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

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:

Principal Quality Engineer

Reports To:

Sr Director, Quality Assurance

Location:

Austin, TX

Business Unit Description:

Recon, Quality

High Level Position Summary:

In this senior role, you will leverage your extensive experience in medical device quality to lead projects improving product quality performance, drive cost-efficient quality initiatives, ensure patient safety through compliance, and support new product introductions from a quality standpoint. As a Principal Quality Engineer, you will serve as a key quality authority on cross-functional teams, mentoring others and guiding strategic quality improvements to help Enovis "create better together" in healthcare.

Key Responsibilities:
 

• Lead the development and execution of quality and validation master plans, protocols (IQ/OQ/PQ), and reports for equipment, utilities, software, and manufacturing processes.
• Ensure validation activities comply with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.
• Lead Quality Improvement Projects: Identify and drive continuous improvement initiatives to enhance product quality and reliability (e.g. reducing defect rates, improving yield). Utilize data from audits, non-conformance reports, and process metrics to prioritize and implement improvements
• Drive Cost Efficiency in Quality Processes: Implement Lean Six Sigma methodologies to reduce the cost of poor quality (scrap, rework, warranty claims) and improve operational efficiency
• Ensure Patient Safety and Compliance: Champion rigorous risk management and quality assurance practices to ensure all products meet safety and regulatory requirements
• Support New Product Introduction (NPI): Collaborate with R&D and Operations on new product development teams to integrate quality at every phase. Lead quality pl