Sr. Quality Engineer

Job Description

Job Description

Contract Sr. Quality Engineer (FDA-Focused, Manufacturing Transfer)
(Austin, Texas). Our client is Austin, Texas has an urgent need for a Contract Quality Engineer to assist team transferring Quality and Training documentation to a new facility.  This position is a Contract without an end date, the right motivated candidate will be encouraged, groomed for Direct Hire. 

The Contract Quality Engineer will provide technical and quality support for manufacturing operations within an FDA-regulated, ISO 13485 medical device environment. The role primarily focuses on supporting the transfer of manufacturing processes, quality systems, and training certifications to a new site. Operational excellence and FDA compliance are top priorities.  Experience reviewing and approving engineering change orders, nonconformances, CAPAs essential.

Summary:
Working with Operations, Manufacturing and Engineering team, the Quality Engineer will be responsible for supporting and maintaining 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.

Key Responsibilities:
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 in all quality and operational activities.
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.

Qualifications:
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/skills that assisting standing up a manufacturing line, experience supporting a new manufacturing line would suffice as well.
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,

About our Client:
Client is a global leader in diagnostic solutions, combining over 50 years of scientific and technological innovation to develop trusted diagnostic assays and instruments. Our products are used worldwide to improve patient care and clinical outcomes.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and 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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.