Quality Control Inspector

Job Responsibilities:

• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Maintain and promote a safe work environment at all times. Identify, address, and react to any unsafe or hazardous situation.
• Conduct inspections, including work in process and final inspection of finished goods to ensure manufactured products conform to specifications. Proficient in identifying and documenting defects, and corrections required.
• Record and maintain quality control records documenting testing and inspections.
• Participate in investigations into non-conforming products and corrective actions.
• Perform manufacturing process audits to ensure correct adherence to Standard Operating Procedures (SOPs) and Work Instructions.
• Initiate Non-Conforming Events (NCEs) within the Quality Management System and assists with investigations relating to non-conforming products.
• Responsible for cleaning, calibrating, and maintaining quality assurance equipment.
• Performs daily reviews of in-process and final test device history records and sales orders.
• Performs inspections to determine pass/fail criteria.
• Participate in Kaizen events and other continuous improvement initiatives.
• Complete all training requirements in a timely manner and maintain accurate training records.
• Regular and punctual attendance. Ability to adhere to standardized production schedule for position and ability to work overtime to support production needs as necessary.

Skills:

• Knowledge of Microsoft Office platform including Excel, Word, SharePoint, and OneDrive required.
• Ability to read, understand, and follow all written procedures.
• Ability to communicate effectively, both written and verbally.
• Ability to work both independently and as a member of a team.
• High-level of attention to detail and focus on quality.
• Detail oriented and accurate.
• Ability to use quality control tools such as measuring tapes, calipers, micrometers, scales, gauges, microscopes, etc.
• Ability to read and interpret basic schematics and blueprints required to ensure proper assembly.
• Understanding of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)

Education/Experience:

• Preferred Minimum Non-Technical Degree: 1-2 Years
• Experience with Oracle ERP or Agile Product Lifecycle Management System is beneficial.
• Previous quality assurance or manufacturing experience is beneficial.
• Experience in an FDA regulated medical device environment is beneficial.
• Preferred Minimum Non-Technical Degree: High School (H.S./GED) or Associate Degree