Sr. Quality Engineer

Location: Austin, Texas, United States; office-based

Applicants must already have full-time work authorization in the United States and must not require employment visa sponsorship.

Company

hirify.global is an innovation-driven medical technology company developing clinically differentiated solutions for orthopedics and related applications.

What you will do

• Provide senior quality assurance leadership for new product development and sustaining engineering programs.
• Lead design and manufacturing reviews, design control documentation, risk management, and compliance with QMS and regulatory standards.
• Lead CAPA investigations, root cause analyses, internal and external audits, and effectiveness verification.
• Develop and execute software verification and validation strategies, including testing of integrations, data interfaces, interoperability, and performance.
• Evaluate quality metrics, complaint trends, nonconforming material, and manufacturing data to identify systemic risks.
• Partner with Engineering, Manufacturing, Regulatory Affairs, Clinical Affairs, Operations, and suppliers on product quality and process validation.

Requirements

• Bachelor’s degree in Biomedical, Mechanical, Manufacturing Engineering, or a related technical discipline.
• 3+ years of quality assurance experience in the medical device industry or another highly regulated industry.
• Strong knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, and applicable international regulations.
• Experience with new product development, Design Controls, CAPA investigations, internal audits, risk management, process validation, and statistical analysis.
• Experience with software as a medical device and software verification and validation documentation, requirements, risk files, protocols, traceability, and objective test evidence.
• Strong technical writing, analytical, communication, leadership, mentoring, and cross-functional influence skills.

Nice to have

• ASQ Certified Quality Engineer, Six Sigma Green Belt, Black Belt, or equivalent certification.
• Experience with FDA inspections, ISO 13485 certification audits, MDSAP audits, IQ/OQ/PQ, and software validation.
• Familiarity with Agile PLM, Oracle, SAP, or Windchill.
• Knowledge of SPC, reliability engineering, and global quality improvement initiatives.

Culture & Benefits

• Collaborative, continuous-improvement-focused environment centered on patient safety and product quality.
• Medical, dental, and vision insurance.
• Spending and savings accounts, 401(k), vacation, sick leave, and holidays.
• Income protection plans, discounted insurance rates, and legal services.
• Office-based work with primarily computer-based activities and cross-functional interaction.