Quality Engineer II

Orthofix•Irvine, CA

About The Position

The Quality Engineer II position at Orthofix is responsible for performing Quality Engineering activities related to product development and existing product support. This role involves approving Quality System documentation, participating in cross-functional development teams to develop and release new products, leading or participating in cross-functional improvement projects and CAPAs, and providing technical support to the QC and calibration departments. Orthofix is a global spine and orthopedics company focused on improving people's quality of life through innovative medical technologies.

Requirements

Bachelor’s degree in engineering, Science, or related field.
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.

Nice To Haves

ASQ Certifications Preferred.
Lean manufacturing/six-sigma hands-on and process/equipment validation experience.

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.
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.
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.