Sr. Quality Engineer

Senior Quality Engineer (Medical Device)

Pay range : 35-45 / hr

The Senior Quality Engineer (QE) actively pursues the ongoing compliance of the North Austin Quality Management system with a focus on process maintenance, measurement, and analysis, continuous improvement activities, and representation of the site during internal and external audits. The Senior QE exhibits quality principles across functions and coaches other engineers in the use of formal root cause investigation tools. This role primarily supports onsite operational and inspection processes for the sites orthopedic devices.

Responsibilities

• Lead the development and implementation of quality programs to ensure products and processes conform to product specifications and applicable regulations (20%).
• Responsible for continuous improvement efforts with respect to Quality Controls to eliminate / reduce future recalls and ensure regulatory requirements and standards are met (20%).
• Lead / participate in CAPA and other non?conforming investigations, identify appropriate actions in response, and act as investigation SME for the site (20%).
• Work directly with cross?functional teams including Operations, Regulatory, Product Development, Supplier Quality, and PMO to ensure projects meet quality system requirements and support successful on?time launches of new products and process transfers (20%).
• Lead or assist in gathering data and formulating strategy for risk?related activities, including MSA, GRR, and FMEA, and may present these risk?related statistics to facilitate decision?making for product, processes, or business (10%).
• Prepare strategy for and represent the site during internal and external audits (5%).
• Other activities as identified and / or agreed with the Site Quality Lead (5%).

Qualifications

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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