CQC Tech 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.