Nobel Biocare Quality Engineer, Manufacturing (On-Site Yorba Linda, CA)

JOB SUMMARY:

The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently produce medical devices that meet specifications. This role supports and ensures compliant execution of New Product Introduction and manufacturing Life Cycle Management activities and drive continuous improvement activities.

PRIMARY DUTIES & RESPONSIBILITIES:

• Support the translation of process risk into PFMEA controls, control plans, standard work and -for-purpose in-process inspection.
• Ensure validations and verifications are robust, and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document, evaluate and track production non-conformances, and lead or facilitate containment, root-cause analysis, NCR and CAPA actions
• Use process, inspection and nonconformance data to detect variation, confirm capability and drive continuous improvement
• Partner with Operations and Engineering to follow standard work, manage changes and maintain accurate, traceable records.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.

 General Quality Accountabilities

• Support internal, and external audits
• Lead supplier audits