Senior Specialist, Quality Systems

Senior Quality Systems Specialist

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.

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

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:

• High School Diploma or equivalent required

Experience, Skills, Knowledge, and/or Abilities:

• 3-5 years' experience in a QA or QC environment
• Prior experience successfully implementing Quality Management Systems and electronic Quality System tools in regulated medical device and/or diagnostic companies
• Expert knowledge of U.S. FDA Quality System Regulations (21 CFR 801, 803, 806, 807 and…