Sr. Quality Engineer

Job Description

Pay range : 35-45 / hr

• depending on experience

Description :

The Senior Quality Engineer (QE) actively pursues the on-going 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 site's orthopedic devices.

What will you be doing?

20% - 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% - Leads / Participates in CAPA and other non-conforming investigations. Identifies appropriate actions in response. Acts as investigation Subject Matter Expert (SME) for the site.

20% - Works directly with cross functional teams including Operations, Regulatory, Product Development, Supplier Quality, and PMO to ensure projects meet quality system requirements. Supports successful on time launches of new products and process transfers.

10% - Leads or assists in gathering data and formulating strategy for risk-related activities, including MSA, GRR, and FMEA. May also present these risk related statistics to facilitate decision-making for product, processes, or business.

5% - Prepares strategy for and represents the site during internal and external audits.

5% - Other activities as identified and / or agreed with the Site Quality Lead.

What will you need to be successful?

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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