Quality Inspector II

Integra LifeSciences Corporation; Northern (KY); On-site; USD 1,524,000 - 44,356,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Quality Inspector II for the 2nd shift to inspect raw materials, in-process items, and finished goods, ensuring dimensions, performance, and appearance meet specifications. You will document inspection data and support calibration and training activities.

The role requires a high school diploma, 1 year in a regulated environment preferred, and ability to read drawings in English.

Qualifications

• High School graduate or equivalent.
• One year in a similar FDA-regulated environment preferred.
• Ability to read drawings and procedures in English.
• Experience with measuring instruments and quality inspections.
• Knowledge of statistical process control is a plus.

Responsibilities

• Inspects labels, pid's, and pouches visually to approve packing operations or other operations.
• Obtains samples, inspects samples to specifications, records inspection data and makes accept/reject decisions based on inspection findings with respect to specifications.
• Verifies dimensions, cavity measures, pressure and other specifications of products, using measuring gauges and testing equipment such as optical comparator, micrometers, calipers, gono-go gauges, pin gauges, microscope, air pressure gauges, and other testing instruments.
• Follows quality control inspection criteria in order to release acceptable lots to store or reject lots to prior operations for re-work.
• Reads written specifications, drawings, and procedures such as the Quality Control Inspection Procedures.
• Fills quality control records, information on shop orders, and maintains other control reports and documentation.
• Assists in training of new Q.A. Inspectors.
• Provides G.M.P./Quality Manual reinforcement and conducts spot audits to manufacturing areas in order to assist production to achieve established goals.
• May be assigned to different workstations as product needs require.
• May use forklift or jack pallets for handling raw materials incoming inspection area.
• Set up and performs destructive and non-destructive test on materials, parts or products to measure performance, material characteristics, etc.
• Maintains quality control records, blueprints, procedures, and other documentation's accurate, updated, and properly organized in files.
• Assures all control documentation are prepared and attached to the corresponding lots.
• Assures that all equipment's are adequately calibrated and informs Supervisor of any discrepancy.
• Assures raw materials or products released to stores or for sterilization fulfill quality standards.
• Maintains work area clean and in orderly conditions.
• Follow Clean Room Rules and Gowning Practices.

Skills

Attention to detail

Reading blueprints

GMP knowledge

Statistical quality control

English reading ability

Education

High School diploma

Tools

Measuring gauges

Micrometers

Calipers

Optical comparator

Job description

## Quality Inspector IIApply: US-PR-Anasco-165-Facility: Full time: Posted Today: JR-6150Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Quality Inspector II** is responsible for tests and inspects raw materials, work in process, and finished goods at various stages of production process. Selects random samples for tests at specified stages such as incoming or in production process, and tests products for variety of qualities, such as dimensions, performance, appearance, correct assembly, and other testing instruments. Records test data, applying statistical quality control procedures. This job description is designed to outline the primary functions and qualifications of this position. This definition does not limit the employee or Integra to just the areas described. It does not identify all tasks that may be required or address performance exceptions, nor does it limit Integra from changing the content. The job description does not constitute an employment agreement between the employer and employee. **This is a 2nd Shift role and the hours are Monday to Friday from 1:30pm tp 10pm.** ## ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.* Inspects labels, pid's, and pouches visually to approve packing operations or other operations.* Obtains samples, inspects samples to specifications, records inspection data and makes accept/reject decisions based on inspection findings with respect to specifications.* Verifies dimensions, cavity measures, pressure and other specifications of products, using measuring gauges and testing equipment such as optical comparator, micrometers, calipers, gono-go gauges, pin gauges, microscope, air pressure gauges, and other testing instruments.* Follows quality control inspection criteria in order to release acceptable lots to store or reject lots to prior operations for re-work. Reads written specifications, drawings, and procedures such as the Quality Control Inspection Procedures.* Fills quality control records, information on shop orders, and maintains other control reports and documentation.* Assists in training of new Q.A. Inspectors.* Provides G.M.P./Quality Manual reinforcement and conducts spot audits to manufacturing areas in order to assist production to achieve established goals.* May be assigned to different workstations as product needs require.* May use forklift or jack pallets for handling raw materials incoming inspection area.* Set up and performs destructive and non-destructive test on materials, parts or products to measure performance, material characteristics, etc.* Maintains quality control records, blueprints, procedures, and other documentation's accurate, updated, and properly organized in files.* Assures all control documentation are prepared and attached to the corresponding lots. Assures that all equipment's are adequately calibrated and informs* Supervisor of any discrepancy.* Assures raw materials or products released to stores or for sterilization fulfill quality standards.* Maintains work area clean and in orderly conditions.* Follow Clean Room Rules and Gowning Practices.* Must use safety shoes in areas that require it or the required protective equipment of the assigned workstation. This applies to all area where safety shoes are required.* Maintains control of raw material quarantine area and printed materials, and discrepant materials in store.* Works on priority orders when released before others to assure compliance with production schedules. Assist the supervisor in any other duty as requested. ## DESIRED MINIMUM QUALIFICATIONS - Education and ExperienceThe requirements listed below are representative of the knowledge, skill, and/or ability required for this position.* High School graduate or equivalent.* One (1) year experience in a similar position in an FDA regulated manufacturing environment preferred.* Driver's license on heavy vehicles highly preferred.* Knowledge of basic math concepts, graphs interpretation, and use of procedures, and inspection methods.* Knowledge of statistical process control techniques.* Ability to read, understand drawings and written documents in English.* Ability to work using testing instruments and manual equipment. Ability to be in a standing position for long periods of time.Salary Pay Range:$11.06 - $15.48 USD HourlyOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training**.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation**.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.