Quality Assurance Specialist

4 weeks ago


Gainesville, Florida, United States Exactech Full time
Job Summary

The Quality Assurance Specialist will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. This role will support supplier quality issues impacting daily operations and ensure compliance to regulation and standards.

Key Responsibilities

Develop and validate statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes, and components.
Support qualification of in-house or vendor supplied inspection equipment.
Support disposition of non-conforming product within the Material Review Board (MRB), coordinating related containment and investigation actions for timely closure.
Responsible for organizing, assisting with, and documenting stock audits for potentially nonconforming product.
Initiate and provide support for distributed product risk assessments and health hazard evaluations. Provide information and records to management regarding potential field actions.
Communicate with suppliers regarding non-conforming product, escalating supplier corrective action requests as required.
Support manufacturing transfer between sites/facilities/suppliers.
Perform general assessment of internal and supplier proposed change management activities.
Identify and implement quality system improvements.
Support Key Performance Indicators (KPIs) for monitoring of process, quality, perform analysis, and interpret trends, identifying appropriate actions as necessary.
Understanding of risk management practices and concepts and applying knowledge to operations.
Perform Root Cause Analysis and support in Corrective and Preventive Actions.
Participate in development and improvement of internal manufacturing processes for existing products.
Support continuous improvement actions to reduce defects and improve process performance.
Support inspection training for QC inspectors or QA technicians.
Perform process audits and GEMBA walks in support of compliance and continuous improvement.
Assist and support cross-functional team members as necessary.
Know and apply the Quality System and any appropriate Federal and International standards.

Requirements

Bachelor's Degree in a science, engineering, or related discipline from an accredited institution required.
Minimum 3 years' experience or equivalent in a highly regulated industry, medical device experience preferred.
Experience in GD&T and use of advanced inspection equipment.
Advanced level of technical software proficiency.
Excellent Quality System knowledge required.

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