Quality Engineer
A highly innovative medical device company is in search of a Quality Engineer to join their fast growing team in Irvine, CA. This is a great opportunity to work at a household name, be a part of a highly innovative organization, and work with state of the art equipment, systems and products.
Come work for a world-wide known company that leads its industry in cutting-edge innovation and breakthrough technology!
Responsibilities:
- Contributes to investigations into production and customer-facing quality issues of medium complexity to identify root cause, implement corrective and preventative actions, and monitor effectiveness. May execute tasks to support higher complexity investigations.
- Demonstrates conceptual understanding and application of role-specific technical and Quality skills
- Develops cross-functional relationships to successfully influence behavior within a team or project.
- Monitors global product performance using a data-driven statistical analysis and risk-based approaches.
- Effectively communicates (written and verbal) technical problems and solutions within small teams and to direct manager.
- Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
- Develops and improves manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
- Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices. Supports internal/external audits.
Requirements:
- Bachelor's Degree or Equivalent years of directly related experience
- 0-1 years of relevant industry experience involving CAPAs, root cause investigations, audits
- Experience in Quality/Manufacturing/Operations/Engineering in Medical Device or Healthcare)