Director, Quality (Medical Devices)

Location: Audubon, PA, United States

Company

hirify.global develops medical technologies and solutions intended to improve surgical techniques and outcomes for patients with musculoskeletal disorders.

What you will do

• Develop and execute the global quality strategy in alignment with company objectives and regulatory requirements.
• Lead and develop Quality Engineering, International Operations Quality, and Sterile Manufacturing Quality teams.
• Oversee design assurance, process validation, risk management, post-market feedback, CAPA, complaints, and nonconformances.
• Maintain quality-system compliance across international manufacturing and distribution sites, including FDA QSR, ISO 13485, EU MDR, MDSAP, Health Canada, PMDA, and TGA requirements.
• Provide oversight of sterilization validation, cleanroom operations, environmental monitoring, aseptic techniques, contamination control, and product release.
• Lead audits, regulatory inspections, corrective actions, quality metrics, and continuous-improvement initiatives.

Requirements

• BS degree or equivalent in Science or Engineering.
• At least 5 years of experience in medical-device quality assurance or quality systems.
• Experience with FDA and CE Notified Body inspections, product quality assurance, process quality, verification, and validation.
• Knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, CAPA systems, and related regulations.
• Computer proficiency with Microsoft Office and statistical-analysis tools, with strong decision-making, presentation, and training skills.
• Travel is required as needed; physical requirements include sitting, climbing or balancing, bending, and lifting up to 25 pounds occasionally.

Nice to have

• Experience with electro-mechanical medical devices, including software.
• ASQ certification or equivalent formal training and experience.
• Knowledge of Lean Manufacturing, Six Sigma, reliability engineering, or a multidisciplinary assurance background.
• Relevant postgraduate qualification.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and decisive execution.
• Focus on improving patient care through advanced medical technology.
• Inclusive and respectful workplace committed to equal employment opportunity and workforce diversity.