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Quality Engineer II
| Company | Orthofix |
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| Location | Irvine, CA, USA |
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| Salary | $95000 – $115000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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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.
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.
- 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.
Preferred Qualifications
- ASQ Certifications Preferred
- Lean manufacturing/six-sigma hands-on and process/equipment validation experience.
