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Enovis · 14 hours ago

Sr. Manager, Quality Engineering

Austin, TX

Full-time

Onsite

Senior Level

7+ years exp

Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions for better patient outcomes. The Sr. Manager, Quality Engineering will lead a team of quality engineers to ensure compliance with regulatory standards, support manufacturing, and foster a culture of continuous improvement.

Health CareManufacturingMedicalMedical DeviceProduct Design

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

Support internal and external audits, acting as a subject matter expert for quality engineering practices

Maintain and improve quality system documentation, including procedures, work instructions, and validation protocols

Qualification

Quality EngineeringISO 13485FDA QSRLeadershipSix Sigma Black BeltQuality System DocumentationCross-functional CollaborationAnalytical SkillsCommunication SkillsProblem-solving Skills