Quality Specialist, Entry Level

Job Description

Quality Specialist | Kelly Science, Engineering, Technology & Telecom

The Tone:
This is an entry-level contract role in Austin, Texas, with potential for conversion to a permanent position. Our client is a global leader in diagnostic solutions, leveraging over 50 years of innovation to create trusted assays and instruments that improve patient care worldwide. This role is crucial for ensuring the successful transfer of manufacturing processes and quality documentation, directly contributing to operational excellence and upholding strict FDA and ISO standards. The individual will support essential quality activities that maintain regulatory compliance and product integrity.

The TL;DR
• Role: Early Career
• Type: Contract, Contract to Hire
• Location: In-person, Austin, TX

• Team: Collaborates closely with Operations, Manufacturing, Engineering, R&D, Regulatory, and Quality Assurance teams.
• Mission: Ensure successful transfer of manufacturing processes, quality documentation, and alignment with FDA and ISO standards for diagnostic solutions.

What You’ll Actually Do
• Compliance Oversight: Ensure all quality inspection activities adhere to FDA QSR (21 CFR 820), ISO 13485, and relevant global medical device standards.
• Record Management: Review, update, and verify device history records, work instructions, validation protocols, and training certification documents for the new site.
• Operational Support: Review production records and assist with non-conformance management, including the review and approval of engineering change orders, nonconformances, and CAPAs as required.
• Documentation Support: Update and maintain training documentation and assist with internal audits during the transition period.
• Meticulous Record Keeping: Maintain meticulous records and use strong technical writing skills while managing risk throughout the process.

The Must-Haves
• Background: Early career professional with an Associates or Bachelor’s degree in life sciences (Biology, chemistry, biochemistry or similar) preferred. Possesses knowledge of FDA QSR (21 CFR 820), ISO 13485, quality documentation, design controls, validation, and CAPA processes.
• Experience: 0-3 years in a manufacturing environment with changing priorities, along with 0-3 years of quality assurance or quality inspection experience, or manufacturing documentation.
• Skills: Skilled in data analysis, risk management, deviation handling, technical writing, and audit support. Demonstrates excellent communication and teamwork skills, with consistent attention to detail.
• Bonus: Familiarity with the medical device, diagnostic, or biotechnology industry, and/or FDA regulations is preferred. Commitment to operational and regulatory priorities is also valued.