Senior Quality Engineer - PATDC5652186

Job Summary :

The Senior Quality Engineer (QE) is responsible for ensuring the ongoing compliance of the Client North Austin Quality Management System. This role focuses on process maintenance, measurement and analysis, continuous improvement, and audit representation. The Senior QE supports onsite operational and inspection processes for orthopedic devices and provides technical leadership in root cause investigations and quality improvement initiatives.

Key Responsibilities :

• Lead the development and implementation of quality programs to ensure products and processes meet specifications and regulatory requirements.
• Drive continuous improvement initiatives in Quality Controls to minimize recalls and ensure compliance with industry standards.
• Lead or participate in CAPA and non-conformance investigations, serving as the site Subject Matter Expert (SME).
• Collaborate cross-functionally with Operations, Regulatory, Product Development, Supplier Quality, and PMO to meet quality system requirements for new product launches and process transfers.
• Conduct risk-related activities such as Measurement Systems Analysis (MSA), Gage R&R, and Failure Mode and Effects Analysis (FMEA), presenting findings to facilitate decision-making.
• Prepare for and represent the site during internal and external audits.
• Perform other duties as assigned by the Site Quality Lead.

Required Skills :

Preferred Skills :

Certifications :

ASQ Certified Quality Engineer (preferred but not required).

Education :

Bachelors Degree in an Engineering discipline (required).

Experience :

Minimum of 6 years in Quality Engineering, preferably in the medical device industry.