2nd Shift Quality Inspector II (Medical Devices)

Integra LifeSciences; Añasco (PR); On-site; USD 15,000 - 21,000; Full time

Job summary

Integra LifeSciences is seeking a Quality Inspector II to inspect raw materials, in-process items and finished goods, recording data and applying SPC methods. The role involves sampling, dimensional checks, and adherence to GMP while supporting production and training junior staff.

The position is 2nd shift (1:30pm–10:00pm) on weekdays, with a focus on ensuring quality standards and accurate documentation across testing instruments and inspection procedures.

Qualifications

• 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.

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 GMP/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.

Skills

FDA regulated environment experience

Statistical process control

Reading drawings

Testing instruments

Math concepts

English reading/comprehension

Heavy vehicle license preferred

Education

High School graduate or equivalent

Job description

Integra LifeSciences is seeking a Quality Inspector II to inspect raw materials, in-process items and finished goods, recording data and applying SPC methods. The role involves sampling, dimensional checks, and adherence to GMP while supporting production and training junior staff.

The position is 2nd shift (1:30pm–10:00pm) on weekdays, with a focus on ensuring quality standards and accurate documentation across testing instruments and inspection procedures.