Engineer Quality Operations
3 weeks ago
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 non-conforming (NC) product within MRB, coordinating related containment and investigation actions for timely NC 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 NC, escalating supplier corrective action requests as required.
- Support manufacturing transfer between sites/facilities/suppliers.
- Performs general assessment of internal and supplier proposed change management activities.
- Identifies and implements quality system improvements.
- Support Key Performance Indicators (KPIs) for monitoring of process, quality, perform analysis, and interpret trends, identifying on appropriate actions as necessary.
- Understanding of risk management practices and concepts and applying knowledge to operation
- 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.
Skills Knowledge and ExpertiseEducation:
- Bachelor’s Degree in a science, engineering or related discipline from an accredited institution required.
- Minimum 3 years’ experience or equivalent in 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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