Sr. Quality Engineer

Contract Sr. Quality Engineer (FDA-Focused, Manufacturing Transfer)

(Austin, Texas) – Our client urgently needs a Contract Quality Engineer to assist with transferring quality and training documentation to a new facility. This is a contract with no end date; the right motivated candidate will be encouraged for direct hire.

Working with Operations, Manufacturing and Engineering teams, the Quality Engineer will support and maintain quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing and development environment. This role ensures compliance with applicable regulatory requirements, including U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO 13485, and other global standards governing medical devices and diagnostic products.

Quality Engineers apply technical knowledge to support product lifecycle processes, including design controls, risk management, process validation, and production quality. This role partners cross‑functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure product quality and continuous improvement.

• Assist in transferring manufacturing operations, quality processes, and documentation (including device history records and SOPs) to a new site.
• Prioritize FDA regulatory requirements and maintain alignment with FDA QSR (21 CFR 820), ISO 13485, and similar standards.
• Develop and revise device history records, work instructions, validation protocols, and training certification documents for the new site.
• Collaborate closely with R&D, operations, manufacturing, regulatory, and quality teams to execute transfer goals.
• Support Design & Site Transfer (DSR) activities and facilitate effective onsite training.
• Update training documentation and participate in internal audits as needed during the transition.
• Maintain accurate records, apply exceptional technical writing skills, and manage risk throughout the process.

• Bachelor’s degree in life sciences, engineering, or related field preferred.
• 2–10 years of quality assurance experience in medical device, diagnostic, or biotechnology industry with proven FDA experience.
• Minimum 3 years experience in manufacturing transfer, including assistance in standing up a manufacturing line or supporting a new manufacturing line.
• Proven experience leading plant‑level operational transitions.
• Experience redesigning layouts, simplifying operations, outsourcing/decommissioning work.
• Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, design control, CAPA, validation, and quality documentation.
• Experience in manufacturing site transfers, device history record development, and training certification documentation.
• Excellent skills in data analysis, risk management, deviation handling, technical writing, and audit support.
• Strong communication and teamwork abilities; attention to detail required.
• Comfortable working in large teams.

Kelly is committed to providing equal employment opportunities to all qualified applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center.

Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.