Position Summary

The QA Technician works closely with the Quality, Manufacturing, Materials and Warehouse departments to assure that all in-coming, in-process and out-going product meet specifications and ensures that all product, process and documentation quality requirements are correct and adhered to.

Essential Duties and Responsibilities

• Performs incoming, in-process and finished inspections for defects, nonconformance and contamination according to Work Instructions (WI’s), Visual Inspection Criteria, SOP’s, and internal specifications specific to each product.
• Performs complete first article inspections, capability measurements and other data collection required by quality and engineering and documents results.
• Records inspection results either manually or electronically and completes appropriate documentation following Good Documentation Practices (GDP) and Good Manufacturing Practices (GDP) in an FDA regulated environment.
• Performs verification or calibration of measurement equipment. Assists in investigations of any out of tolerance calibration results.
• Sources, schedules and generates purchase orders for outside calibration services.
• Maintains and updates the calibration recall system.
• Performs monitoring of controlled environments to verify continued compliance.
• Reviews and updates work instructions, quality plans and other quality related documentation as needed.
• Follows documented procedures to maintain control of nonconforming products by identifying and segregating products that do not meet specifications and completes appropriate documentation.
• Utilizes a variety of mechanical and electronic testing equipment, including various hand tools, calipers, microscopes, mechanical pull testing equipment, CMM and vision systems.
• Performs receiving inspection of raw materials using appropriate sampling plan and measuring/test equipment.
• Maintain status of incoming raw materials and supplies in appropriate software system (i.e. received, released, on hold, etc.).
• Packages and labels components in preparation for release and reviews supplier certifications/packing list to ensure compliance with specification.
• Reviews DHR requirements and ensures all document is complete prior to finalizing and closure of DHRs.
• Generates certification documentation to accompany shipments.
• Files and maintains DHRs, quality records, calibration records and finished goods retention samples.
• Conducts extensive data collection to support the identification of trends to increase yields through process improvement.
• Understanding of GMP requirements, following QMS documentation to complete job requirements.
• Has a firm understanding of ANSI Y 14.5 Dimensioning and Tolerancing
• Follows good manufacturing practices at all times.
• Maintains a neat, safe and clean work area
• Supports quality system objectives.
• Follows all QA procedures and work instructions as applicable.
• Follows established safety requirements and adheres to policies and procedures.
• Performs other job-related responsibilities as assigned.

Required Competencies, Skills and Experience

• Strong attention to detail.
• Familiarity of inspection tools and gages.
• Knowledge of computers/software

Preferred Skills

• Strong math and communication skills.
• Good comprehension of GD&T concepts.

Education and Job Experience Requirements

• High school diploma or GED required.
• Minimum 2 years’ experience in Quality control.

Work Environment and Physical Demands

• Must be able to lift up to 25 lbs.
• While performing the duties of this Job, the associate may be exposed to equipment and moving mechanical parts.
• The employee is occasionally exposed to fumes or airborne particles.
• Employee may be exposed to extreme temperatures and humidity.
• While performing the duties of this job, the employees is regularly required to use hands to handle, or feel objects, tools, or controls. The employee frequently is required to talk, hear and use machinery; reach with hands and arms; and grasping with hands. The employee is frequently required to sit, walk; bend; twist; push and pull; stoop, twist; and crouch. Employee is occasionally required to stand, squat; climb; and kneel.

The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.