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. 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. JOB PURPOSE The position is responsible for performing Quality Engineering activities related to product development and existing product support. The Quality Engineer II approves Quality System documentation, participates in cross functional development teams to develop, and release new products, participates/lead cross functional improvement projects and CAPAs, and provides technical support to the QC and calibration departments. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned. 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. Leads Risk Management activities and ensures 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: Develops and maintains 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 Validations 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 The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position. Education/Certifications: Bachelor's degree in engineering, Science, or related field Experience Skills, Knowledge and/or Abilities: Minimum 2 years working in the medical device industry is required. 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. Able to independently manage projects and lead cross functional teams. Strong writing and verbal communication skills and ability to multi-task in fast paced environment. PREFERRED QUALIFICATIONS The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above. Education/Certifications: ASQ Certifications Preferred. Additional Experience, Skills, Knowledge and/or Abilities: Lean manufacturing/six-sigma hands-on and process/equipment validation experience. PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS The physical requirements listed in this section include, but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. 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 the position. No additional physical requirements or essential functions for this position. The anticipated salary for this position for an employee who is located in California is $85,000 to $118,000 per year, plus bonus, and benefits. DISCLAIMER The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status. We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, 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. Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide. Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company's global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil. Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients' lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.