Associate Manager, Quality Engineering (Medical Devices)

Location: Office/manufacturing-site based in Austin, Texas, United States

Company

hirify.global is a medical technology company developing clinically differentiated orthopedic solutions and integrated technologies to improve patient outcomes.

What you will do

• Provide technical guidance, supervision, coaching, and development support to Quality Engineers and other Quality team members.
• Partner with Manufacturing and Operations to resolve production and quality issues, support transfers, new product introductions, process changes, and continuous improvement.
• Lead risk-based investigations, Material Review Board activities, root cause analysis, CAPA, and corrective-action effectiveness verification.
• Lead or support process and equipment validation, including IQ/OQ/PQ/TMV, and review related protocols, reports, and engineering documentation.
• Manage supplier quality activities, including investigations, SCARs, supplier monitoring, transfers, and change management.
• Monitor quality metrics, identify trends and systemic risks, update quality procedures, and support internal, external, and regulatory audits.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• 5+ years of Quality Engineering, Manufacturing Engineering, or related experience in a regulated manufacturing environment.
• Experience in medical device, aerospace, automotive, or another highly regulated manufacturing industry; medical device experience is strongly preferred.
• Experience leading projects, mentoring employees, providing technical leadership, and supporting manufacturing transfers and IQ/OQ/PQ validation.
• Experience with root cause analysis, CAPA, nonconforming material, structured problem-solving, and technical quality documentation.
• Must already have full-time work authorization in the United States without requiring current or future employment visa sponsorship. Must communicate clearly and fluently in English.

Nice to have

• Working knowledge of FDA Quality System requirements, GMP, and ISO 13485.
• CQE, CQA, Lean, Six Sigma, or similar quality certification.
• Knowledge of metrology, precision machining, grinding, product cleaning, and sterilization.
• Experience making data-driven decisions and influencing cross-functional stakeholders.

Culture & Benefits

• Culture focused on quality, accountability, collaboration, scientific excellence, and continuous improvement.
• 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 an equal employment opportunity workplace.