US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
Senior Quality Specialist at NuVasive Manufacturing is responsible for the development, implementation, and improvement of manufacturing quality plans. Participate in Production and Process Control activities and provide guidance to Process Development as well as support quality system and production processes by developing inspection /testing plans, performing risk analysis and developing process validation protocols and reports to ensure the quality of new and modified products and processes in a CNC Manufacturing environment.
Supporting Process Development & Production Transfer Activities including:
· Quality planning: establish and implement timely risk analysis, control plans, and inspection plans for in-process and final inspection. Enlists appropriate engineering or technical assistance to develop adequate inspection criteria, if needed.
· Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action.
· Identify opportunities, coordinates development of criteria and documentation, to facilitate suppliers’ performance of quality inspections
· Designs and procures production gaging when appropriate.
· Evaluate and qualify manufacturing processes to ensure technical requirements can be met. (MSA, Cpk, assembly validation, etc.)
· Provide process development and operations with inspection criteria prior to manufacturing. Manage process validations and process improvements.
· Planning, execution and responding to QMS documents & problem resolution.
· Manage corrective actions, rework plans, deviations, and non-conformances.
· Issues corrective actions and drives root cause investigation and corrective action implementation.
· Assist & support CAPA Program with analysis and efforts relative to product quality issues including analysis of CAPA program data and identify/trend quality issues.
· Planning, execution and ensuring department goals are met.
· Train, guide, influence and mentor Jr. or new members of the Quality team.
· Participate in resource planning, recruiting, and budgeting. Attend project meetings and establish activity timelines to meet department and company Goals and Objectives.
· Duties to be performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21: CFR 820, ISO 13485, and the European Medical Device Directive.
· Effectively teach, train, and mentor others across all functions
· Ability to effectively influence others, develop consensus, and create support throughout the organization.
A bachelor degree or equivalent experience. Five to eight years of experience in a regulated environment in Quality Assurance and/or Quality Engineering in a Manufacturing environment required (QSR, ISO 13485, and the MDD).