Senior Incoming Inspection Supervisor

Responsibilities

• Leads team in predetermined methods, operations, setups and prescribed specifications to inspect visually in-process and completed products.
• Uses various measuring devices and testing equipment.
• Accepts, rejects, or reworks defective or malfunctioning units or systems.
• Works from blueprints, diagrams, dial indicators, preset micrometers, scales, fixtures, customer specifications, drawing or inspection instructions and checklists.
• May monitor and verify quality in accordance with statistical process or other control procedures.
• Performs line clearances after each lot to ensure all materials from the previous lot have been removed.
• Assures smooth operating of the inspection unit, maintaining daily records and reports.
• Prioritizes schedules based on product introduction and manufacturing schedules.
• Makes recommendations for capital expenditures and manpower for inspection area.
• Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
• Recommends new or enhanced methods, procedures and standards.
• Drives risk burndown activities by identifying quality risks, recurring defects, inspection escapes, and process gaps.
• Leads and supports Quality Management System improvements.
• Leads efficiency projects focused on improving inspection throughput.
• Maintains audit readiness for the inspection area.
• Supports audit activities and inspection responses.
• Oversees MRB activities and NCMR product management.
• Partners cross-functionally with Manufacturing, Quality, Engineering, Supply Chain, and Operations to drive timely disposition of nonconforming material.
• Monitors trends in defects, MRB, NCMR, rework, and inspection performance.

• Requires advanced knowledge of job area typically obtained through advanced education combined with experience.
• Requires 3+ years of experience with a high school diploma or equivalent.
• Experience in a regulated medical device or FDA / ISO 13485 manufacturing environment.
• Working knowledge of MRB, NCMR, CAPA, and nonconforming product disposition processes.
• Experience supporting internal, external, customer, or regulatory audits and driving audit readiness activities.
• Lean Sigma, continuous improvement, or process optimization experience with demonstrated efficiency gains.
• Experience with electronic quality systems, and data-driven decision making using quality or inspection metrics.

Demonstrates expertise in quality management systems, inspection processes, and regulatory compliance within a medical device manufacturing environment. Proficient in leading teams, driving continuous improvement initiatives, and ensuring audit readiness.

• Inspection Processes
• Statistical Process Control
• Defect Identification
• Quality Metrics Analysis
• Process Optimization
• Blueprint and Diagram Interpretation
• Measuring Device Usage
• Nonconforming Product Disposition
• Risk Burndown Activities
• Efficiency Project Leadership

• Team Leadership
• Cross-Functional Collaboration
• Effective Communication
• Problem Solving
• Personnel Development

• ISO 13485 Knowledge
• Lean Sigma Certification

• Electronic Quality Systems
• Testing Equipment
• Measuring Devices
• Inspection Checklists
• Quality Control Software