Title: QA Specialist II
Location: Austin, TX
Duration: 12 Month Assignment, with potential extensions
100% onsite
Position Overview
This role supports third-party medical devices by managing device history records and batch records. The primary responsibilities include batch review, quality document approvals, and ensuring compliance with medical device regulatory standards.
Key Qualifications
- Education: Bachelor’s degree required, preferably in STEM (Engineering/Science fields are ideal).
- Experience: Minimum of 3 years in a regulated medical device or pharmaceutical manufacturing environment. (Internships, co-ops, and schooling will not count toward experience.)
- Strong documentation skills, with experience in batch reviews, quality document approvals, and lab notebooks (design, manufacturing, or release).
- Familiarity with non-conformances and CAPA processes is a plus.
- Proven ability to follow procedures, ensure compliance, and escalate issues as necessary.
- Exceptional attention to detail and strong understanding of medical device quality documentation.
Top Skills Required
- Ability to follow detailed procedures.
- Strong attention to detail and accuracy.
- Proficient in managing and understanding medical device quality documentation.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.