Staff Quality Engineer (Orange County)

JOB TITLE : Senior or Principal Quality Engineer (depending on experience)

DEPARTMENT : Quality Assurance

REPORTS TO : Director, Quality

General Summary

This position will work closely with counterparts within all functional groups to assure that our clients Quality System is maintained, and products are designed and produced in accordance with the applicable Regulatory and Company requirements.

ESSENTIAL JOB FUNCTIONS (Included but not limited to)

• Provide guidance on product and process validations, including sterilization validation / revalidation
• Lead biocompatibility studies
• Creating and / or Updating Risk Management documents as per ISO 14971 for new products or product design changes
• Represent Quality Assurance on Design Control project teams for new or revised products
• Investigate product or production issues and develop the associated corrective action(s)
• Oversee and help maintain the Calibration and Preventive Maintenance Systems
• Provide competence in Supplier Evaluations / Development / and Monitoring
• Support the maintenance of a quality system in compliance with our clients Quality Policy and the applicable regulatory standards / requirements for medical devices
• Provide support for Regulatory Submissions and Audits as applicable
• Signature authority for Quality in changes to Manufacturing / Quality procedures, processes, design, etc.
• Provide Training and Direction for Quality Inspectors and Technicians

EDUCATION AND / OR JOB EXPERIENCE

SPECIAL SKILLS, ABILITIES, AND REQUIREMENTS

The above job description is intended to describe the general content, identify the essential functions and requirements for the performance of this particular position. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.