Quality Engineer – ISO 13485
Must have experience with ISO 13485 and must be hands on
Perform Root cause analysis and Corrective Action including Documentations per ISO 13485 requirements. Review corrective actions and Identify gaps if any and work with other teams to close identified gaps.
Knowledge and experience in Supplier Audit activities in accordance with ISO 13485. Perform Supplier Audit and issue reports in accordance to our Supplier approval and qualification program. Review and assist Supplier approval documentations.
Review and assist in the Product and Process V&V activities for new Project
Knowledge of packaging validation and requirements
Review and audit records for finished goods products per established process
Audit and Review Non Conformances Report (NCMR) identify gaps if any and work with others to close identified gaps
Good communication and problem solving skills
Ability to work independently with minimal supervision
Prefer B.S. degree in related activities.Compensation: Competitive / DOE
Position Type: 40 hours/week, on site
Start date: Immediate