Quality Engineer II

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. Job Purpose The position is responsible for performing Quality Engineering activities related to product development and existing product support. The Quality EngineerII approves Quality System documentation, participates in cross‑functional development teams to develop and release new products, leads cross‑functional improvement projects and CAPAs, and provides technical support to the QC and calibration departments. Essential Functions and Responsibilities Lead cross‑functional project teams as needed to accomplish quality objectives. Review and approve Quality System documentation in compliance with SeaSpine’s procedures, cGMP requirements and statutory requirements (US FDA, ISO, MDD and MDR) including protocols, technical reports, validation/quality plans, standard operating procedures, risk analysis, design control documents, drawings, and specifications. Facilitate the launching of new or improved products, and the transfer of technology from development to commercialization from a Quality perspective. Develop Design History File deliverables to support timely product launches while ensuring compliance with Quality System and Design Controls principles. Lead Risk Management activities and ensure that appropriate Risk Management tools (AFMEA/DFMEA/PFMEA) are utilized and consistent with applicable regulatory standards. Review outputs of Risk Analyses and lead cross‑functional efforts to identify appropriate risk mitigation activities. Support sustaining activities, Quality Control and Calibration department: develop and maintain inspection plans using appropriate methodologies to ensure products meet specification and are safe/effective for use. Facilitate MRB activities as assigned by QA management. Support Calibration and Preventive Maintenance activities. Conduct Out of Tolerance investigations. Develop statistically based sampling plans for in‑process inspection, final testing, and validations. Interface with contract manufacturers to develop inspection techniques and support non‑conformance investigations. Use quality engineering tools for problem solving (e.g., DMAIC, SPC, DOE). Identify and implement opportunities for continuous improvement. Interact and coordinate activities with other departments, external vendors, and customers. Assist or lead in the prompt implementation of Quality related projects including: Non‑Conformance resolution, Complaint Investigation and Corrective & Preventative Action(s) (CAPA), Process Validation development and implementation of new and updated Quality System procedures for ISO/QSR compliance; create/support in‑house and supplier process validations using IQ, OQ, PQ methodology including cleaning, water system, sterilization, and software validations; prepare information for Quality Management Reviews and Operational Reviews such as trend charts, Pareto Analysis, etc., as required; participate in FDA inspections, ISO certification and surveillance audits and customer audits. Minimum Qualifications Bachelor’s degree in engineering, science, or a related field. Minimum 2 years working in the medical device industry. Understanding of medical device Design Control and Quality System requirements including 21CFR820, ISO13485, and ISO14971. Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity. Demonstrated experience and understanding in the use of statistical tools. Ability to independently manage projects and lead cross‑functional teams. Strong writing and verbal communication skills and ability to multi‑task in a fast‑paced environment. Preferred Qualifications ASQ certifications preferred. Lean manufacturing/six‑sigma hands‑on and process/equipment validation experience. Physical Requirements / Adverse Working Conditions In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of this position. No additional physical requirements or essential functions for this position. Equal Employment Opportunity We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, national origin, disability, gender identity, sexual orientation, protected class status, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment. #J-18808-Ljbffr