Director, Quality Operations

Why Orthofix?
    

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.  

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

How you'll make a difference?

The Director of Quality Operations is responsible for the production quality function at the Lewisville, Texas site, ensuring manufacturing and inspection programs and processes are in place to ensure compliance with Orthofix Quality Standards, FDA, and applicable OUS regulations.  The Director of Quality Operations is responsible for leadership and supervision of the manufacturing quality team including incoming inspection, product release, monitoring of in-house and supplier operations, calibration monitoring, and product distribution. The Director of Quality Operations will support and drive improvements across the entire lifecycle of products, including manufacturing process design, inspection plans, change control, deviations, complaint management, and performance data review. In addition, the Director of Quality Operations partners closely with other functions to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory expectations.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Manage quality oversight to ensure Good Manufacturing Practice (GMP) internally and at suppliers during the manufacturing, handling, and shipping of the Company’s products.

• Manage production batch records for final approval and product release.

• Review and approve other GMP documents including, but not limited to, manufacturing validation protocols and reports, and transportation studies.

• Lead and provide oversight for processing change control requests, nonconforming product dispositions, and CAPA investigations related to production.

• Work with various departments to plan and schedule Quality Control (QA) and Quality Assurance (QA) resources.

• Lead and provide oversight with respect to the proper administration and adherence of all policies and procedures to sustain a state of current Good Manufacturing Practices (cGMP) compliance at the Company.

• Active participant in GMP audits and inspection readiness activities to ensure Company is in a constant state of inspection readiness.

• Interact with government agencies during GMP inspections.

• Actively participate in continuous improvement activities with cross-functional teams. 

• Pursue improvements in inspection techniques and key production metrics through the use of test method validations and statistical process monitoring.

• Manage supplier quality through continuous monitoring and continuous improvement activities with internal cross-functional teams and supplier teams.

• Direct and oversee the Calibration program.

• Lead Global alignment activities on Operations Quality topics.

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Bachelor’s degree or equivalent experience

Experience, Skills, Knowledge and/or Abilities:

• 15 years of related experience.

• Knowledge of domestic and international medical device quality system laws, regulations, and standards.

• Able to interpret medical device law into workable, efficient, and effective practices, and procedures.

• Personnel Management

• Experience with ERP systems, electronic document, and record management systems.

• Knowledge of configuration management.

• Able to lead and make independent decisions.

• Excellent communication skills.

• Able to adjust priorities as requir