Inspector I

Summary: 

Ability to inspect in-process and finished products in the cleanroom environment. Act as coordinator within Quality Operations and ensure needs of internal customers are met. Document all non-conformances when necessary.  Assist with investigations pertaining to, both, customer complaints and internal non-conformances.  Understand, follow, and practice the rules/regulations set forth by the QSR, ISO 13485, and Quest Medical management. 

General Duties and Responsibilities: 

• Review processes to assure procedural compliance and recommend improvements 

• Provide support during internal, customer and regulatory audits  

• Ability to identify key inspection points and the proper tools/equipment to ascertain these points. 

• Perform inspections and verification of finished products.  

• Perform Line clearance and in-process inspections.  

• Review inspection data and DHRs (including sterilization records) for accuracy and compliance to the applicable standard(s).   

• Perform inspections and process Returned goods/ materials (RGAs/RMAs).  

• Evaluate materials for extending Expiration dates.  

• Use recognized sampling plans to determine statistical size of samples 

• Perform and review tests according to various protocol requirements  

• Document and review inspection results per GMP/GDP. 

• Provide/coordinate training for new Technicians. 

• Generate non-conforming material reports (NCMR) for products that do not conform to test specifications and contact the appropriate personnel.   

• Communicates needs of department/company to management.  

• Coordinate needs of internal customers and communicate to technicians in his/her area of responsibility.  

• Assist engineering staff with process improvement projects regarding improved quality inspection of product and components (such as First Article Inspections and qualification testing) 

• Evaluate certification status of raw materials under the Supplier Certification program.  

• Ability to work in Quality Operation areas Cleanroom In-Process QC, Finals QC.  

• Ability to work on projects related to new instrumentation.  

• Ability to redline documents for improvements or compliance.  

• Ability to use pallet jack to move materials.  

• Ability to lift materials weighing up to 50lbs. 

Qualifications: 

• High School graduate or equivalent work-related experiences with some previous quality control experience desired (minimum of 5 years). 

• Strong inspection ability using a caliper, micrometer, vision system including optical comparator, OGP Smart system, and other inspection and measurement tools. 

• Detail oriented, computer literate and possesses a professional demeanor, be adaptable to changing environments and capable of completing tasks with little or no supervision. 

• Computer skills including MS Office (basic knowledge). 

• Good written and oral communication skills are required and must be able to read, write, and understand English.  Interpersonal skills dealing with other departments/individuals in a team atmosphere important. 

• Ability to read and interpret engineering DWGs, product specifications, and procedures and use metrology and other testing equipment. 

• Medical device experience desired.