Senior Technical Quality Lead (Medical Devices)

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Aurora Lifesciences seeks a Technical Quality Lead to act as the quality authority across product development, manufacturing and the Quality Management System.

This senior, hands-on role emphasizes technical leadership over people management, collaborating with Engineering, Manufacturing and Quality to ensure design controls, risk management and regulatory compliance are embedded throughout the product lifecycle.

Qualifications

• Significant Quality Engineering experience in medical devices or regulated tech
• Experience with new product development (NPD)
• Deep knowledge of ISO 13485, ISO 14971, 21 CFR 820 and EU MDR
• Hands-on design controls and design verification/validation
• Experience with manufacturing environments and process validation

Responsibilities

• Act as senior Quality Engineering representative across new product development and technical projects.
• Provide technical quality leadership through product development, validation, transfer and manufacturing.
• Critically review and approve design, process and product changes.
• Partner with Engineering and Manufacturing to develop robust manufacturing processes.
• Lead or direct design verification and validation activities.
• Support development and implementation of design control documentation.
• Investigate non-conformances using root cause analysis and CAPA.
• Develop and oversee corrective and preventive actions.
• Provide guidance on process validation and equipment qualification (IQ/OQ/PQ).
• Support sustaining engineering, process monitoring, change control and disposition of non-conforming material.
• Own or act as SME for key elements of the Quality Management System.
• Apply risk management throughout development and manufacturing.
• Support internal audits, supplier quality activities and regulatory inspections.
• Provide input into post-market quality and product performance.
• Coach and mentor Quality Engineers and technical colleagues.
• Translate complex quality information to technical and non-technical stakeholders.

Skills

Quality Engineering

New product dev

Regulatory compliance

Root cause analysis

CAPA

Process validation

Equipment qualification

Risk management

Documentation review

Stakeholder management

Education

Engineering degree

Job description

Aurora Lifesciences seeks a Technical Quality Lead to act as the quality authority across product development, manufacturing and the Quality Management System.

This senior, hands-on role emphasizes technical leadership over people management, collaborating with Engineering, Manufacturing and Quality to ensure design controls, risk management and regulatory compliance are embedded throughout the product lifecycle.