Senior Specialist, Quality Systems

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.

The Senior Quality Systems Specialist is responsible for ensuring the Orthofix Quality System complies with all domestic and international laws and standards. This includes performing internal audits, assisting with external audits, and ensuring all written standards are regularly reviewed and up to date. The role involves continuous quality improvements, maintaining and supporting the Corrective/Preventive Action System, and managing controlled documentation and supporting LMS and PLM Systems.

Additionally, the specialist ensures compliance with the FDA's Global Unique Device Identification Database (GUDID) requirements and supports labeling activities in the medical device industry.

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

• Quality Management System Enhancement:
  Reviews and recommends improvements to the Quality Management System (Quality Manual, Standard Operating Procedures, and Work Instructions) Collaborates with cross-functional teams to implement and enhance electronic Quality System tools Facilitates cross-functional process improvement teams to drive operational excellence Gathers, compiles, and reports on Quality data Reviews documents to ensure the Quality System complies with all applicable laws and standards and is as efficient and effective as possible
• Develop and Deliver Training:
  Administers the online training program for the Quality Management System Designs, delivers, and evaluates the QMS training program Generates monthly training reports to ensure training effectiveness and compliance Continuously updates training matrices for efficiency Supports project teams in implementing quality requirements and procedures Provides cGMP and ISO training to employees
• Conduct and Ensure Compliance:
  Schedules and executes internal audits to ensure all quality system elements are audited at least annually Conducts monthly internal walkthroughs to support audit readiness Prepares, investigates, and follows up on verification activities associated with the Corrective/Preventive Action system Assists the Head of QA department with preparation for and activities associated with external audits by FDA, Notified Body, and others
• Document Control and Data Management:
  Assists the Document Control department with processing DEV, ECO, ECOT, and MCOs as needed Ensures all necessary written standards, both systemic and product-specific as defined by Engineering, are up to date and available for use
• Post-Market Surveillance and Support:
  Assists the Post-Market Surveillance department with initiating DIFs Coordinates with Product Development and Marketing Team to close the Device Investigation. Ensuring parts match complaint descriptions
• General Responsibilities:
  
  Supports company and department goals and objectives Prepares, submits, and manages GUDID data to the FDA Maintains the accuracy and completeness of device information within the GUDID, ensuring device labelers meet their UDI obligations

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

• Education/
  
  Certifications:
  
  High School Diploma or equivalent required
• Experience, Skills, Knowledge, and/or Abilities: 3-5 years’ experience in a QA or QC environment Prior…