Design Quality Engineer

About the role

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 .

Responsibilities

• Essential Duties and Responsibilities:
• Support Design Quality Engineering Assignments, including New Product Introduction (NPI) projects, Corporate priority projects and sustaining support. Quality Engineering Responsibilities may include:
• Support, Review and Approve Design Specification packages
• Support, Review and Approve Material and Product Test Plans
• Review and Approve Design Engineering Drawings
• Review and Approve Design Verification and Validation Test Protocols and Reports
• Support Design Transfer activities: Develop inspection and testing methods, plans to perform First Article Approvals and lead execution of First Article inspections.
• Support Sustaining Design Quality Engineering Assignments, including ensuring verification and validation for design changes for product and process improvements, component end of life transition, and quality improvements.
• Lead Risk Management process for assigned products and projects, coordinating development and implementation of risk management plans, hazard analyses, design and process failure modes and effects analyses (as applicable).
• Support Design History File establishment, creation, approval and maintenance
• Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations and company policies and procedures.
• Coordinate Supplier Approvals for NPI projects with Supplier Quality Assurance in accordance with DJO Supplier Approval process.
• Support, Review and Approve Design Transfer activities to ensure design quality performance requirements are properly transferred, which may include IQ, OQ, PQ, Process Validation, and updated Inspection Plans.
• Attend and support Project team meetings, collaboration sessions and other collaboration activities.
• Support Design Review and Change review meetings; review and decide disposition of obsolete revision materials.
• Support Cost of Poor Quality Initiative, by developing and executing site projects to reduce the costs associated with poor quality
• Support DJO Corrective and Preventive Action Process
• Lead Supplier Corrective Action program, communicating and coordinating CAPA completion of suppliers.
• Review CAPA assignment responses for completeness and validity.
• Support Internal CAPA Program as required, including by example and not exclusion performing CAPA investigations and improvement implementation, verifying implementation and effectiveness of improvements.
• Conduct internal audits:
• Conduct interviews, summarize observations, conduct closing meeting with Department Supervisors
• Enter non-compliances into the Agile system and trend software, and follow-up with process owners until CAPA is closed.
• Assist in

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