Sr. Quality Engineer - Enabling Technology (Medical Devices)

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

Company

hirify.global is a medical technology company developing clinically differentiated orthopedic and related solutions to improve patient outcomes and transform healthcare workflows.

What you will do

• Provide senior quality assurance leadership for new product development and sustaining engineering programs.
• Lead design and manufacturing reviews for compliance with QMS requirements and regulatory standards.
• Lead risk management activities, including DFMEA, PFMEA, and ISO 14971 documentation.
• Review and approve design controls, engineering changes, validation documentation, and quality records.
• Lead CAPA investigations, root cause analyses, internal and external audits, and regulatory inspections.
• Develop software verification and validation strategies and perform testing for integrations, data interfaces, interoperability, and performance.

Requirements

• Bachelor’s degree in biomedical, mechanical, manufacturing engineering, or a related technical discipline.
• At least 3 years of quality assurance experience in the medical device industry or another highly regulated industry.
• Strong knowledge of FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971, and applicable international regulations.
• Experience with design controls, CAPA investigations, internal audits, risk management, process validation, and statistical analysis.
• Experience with software as a medical device and software requirements, design documentation, risk files, test protocols, traceability, and objective evidence.
• Must already have full-time work authorization in the United States without requiring employment visa sponsorship.

Nice to have

• ASQ Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt, or equivalent certification.
• Experience with FDA, ISO 13485, and MDSAP inspections or certification audits.
• Familiarity with Agile PLM, Oracle, SAP, Windchill, or other PLM and ERP systems.
• Experience with SPC, reliability engineering, and global quality improvement initiatives.

Culture & Benefits

• Office-based work in a clean, organized, and well-lit environment with cross-functional interaction.
• Medical, dental, and vision insurance.
• Spending and savings accounts, income protection plans, and discounted insurance rates.
• 401(k) plan, vacation, sick leave, and holidays.
• Legal services and a focus on continuous improvement, patient safety, and collaborative quality outcomes.