Quality Control Technician

Description

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 the company's internal guidelines

Requirements:

• 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 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 drawings, product specifications, and procedures and use metrology and other testing equipment.

• Medical device experience desired.

Skills

Quality control, Troubleshooting, caliper, micrometer, inspection, QC, Pneumatics, Mechanical, electrical testing

Additional Skills & Qualifications

Duties:

• Review processes to assure procedural compliance and recommend improvements

• Perform and review visual, dimensional and functional inspection of incoming raw materials 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 standards

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

• Use recognized sampling plans to determine statistical size of samples

• Perform and review tests according to various GMP protocol requirements

• Document and review inspection results per GMP/GDP

• 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.

• Execute and maintain 5S environment.