Manufacturing Quality Assurance Manager (Medical Devices)

Location: US-TX-Cedar Creek; occasional travel required

Salary: $127,680–$199,500 per year, plus eligibility for bonus, stock, and benefits

Company

hirify.global provides scientific and analytical technologies and operates a regulated manufacturing site requiring strong quality and compliance oversight.

What you will do

• Lead, coach, and develop a team of Manufacturing Quality Assurance professionals.
• Oversee manufacturing quality activities, product testing, documentation, batch record review, product disposition, and release.
• Maintain inspection readiness and support internal, customer, and regulatory audits.
• Manage quality system processes including deviations, investigations, nonconformances, CAPA, change controls, and rework.
• Oversee equipment, process, system, and method qualification and validation activities.
• Analyze quality metrics and trends, communicate risks, and lead continuous improvement initiatives.

Requirements

• Bachelor’s degree in science, engineering, quality, or a related technical field.
• At least 8 years of quality experience in a regulated manufacturing environment and at least 3 years of people leadership experience.
• Experience with Quality Management Systems, audits, inspections, regulatory agencies, and external auditors.
• Strong knowledge of FDA regulations, ISO 13485, and cGMP requirements.
• Experience with quality metrics, risk management, data analysis, root cause investigations, and corrective actions.
• Ability to travel occasionally as business needs require.

Nice to have

• Advanced degree or professional quality certifications.
• Medical device or diagnostics manufacturing experience.
• Experience driving Lean/Six Sigma and sustainable quality improvements.

Culture & Benefits

• Full-time day-shift schedule with no specified end date.
• Opportunity to contribute to site Quality Leadership Team governance and cross-functional decision-making.
• Eligibility for bonus, stock, and benefits.
• Inclusive, merit-based workplace committed to equal employment opportunity and accessibility.