Senior Manager, Quality Assurance (Medical Devices)

Location: Fort Worth, Texas, United States; applicants must already have full-time work authorization in the United States and must not require employment visa sponsorship.

Company

hirify.global is a medical technology company developing clinically differentiated solutions for orthopedics and related applications.

What you will do

• Lead and mentor quality engineers and technicians, providing technical guidance and performance management.
• Develop quality strategies aligned with business objectives and regulatory requirements.
• Support manufacturing operations and new product introduction through process controls, risk management, and production-method validation.
• Drive root cause analysis, CAPA, product and process improvements, and operational efficiency.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges.
• Support internal and external audits, maintain quality documentation, serve as the LiteCure Quality Management System Management Representative, and qualify as a laser safety officer for the DFW location.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Industrial, or related Engineering; a Master’s degree is preferred.
• 8+ years of quality engineering experience in medical devices or other regulated industries, including 3+ years in a leadership role.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), and ISO 14971.
• Proven ability to lead cross-functional teams and manage complex projects.
• Excellent communication, analytical, and problem-solving skills.
• Full-time U.S. work authorization is required without current or future sponsorship needs.

Nice to have

• ASQ CQE, CQM, CQA, or Six Sigma Black Belt certification.
• Familiarity with eQMS systems, statistical software, and metrology tools.
• Demonstrated success in quality improvement and regulatory compliance.

Culture & Benefits

• Culture focused on collaboration, scientific excellence, continuous improvement, and patient outcomes.
• 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 equal employment opportunity.