Job Description

Summary :

Inspect incoming raw materials pertaining to Disposables and Electronics. Inspect Finished products. 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
• Perform and review visual, dimensional and functional inspection of incoming raw materials using caliper, micrometer, vision system including optical comparator, OGP Smart system, and other inspection and measurement tools, pertaining to Disposables and Electronics. Ability to identify key inspection points and the proper tools/equipment to ascertain these points.
• Perform inspections and verification of finished products.
• 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 IQC 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.
• Assist engineering staff with process improvement projects regarding improved quality inspection of product and components (such as First Article Inspections and qualification testing)
• Ability to work in all QA areas (IQC, Finals and Electronics) if needed.
• Ability to use pallet jack to move materials.
• Ability to lift materials weighing up to 50lbs.
• Execute and maintain 5S environment.

Qualifications :

• High School graduate or equivalent work-related experiences with some previous quality control experience desired (2 to 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 Excel and MS Access (basic knowledge of each).
• 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.

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