Quality Inspector I

Integra LifeSciences; Añasco (PR); On-site; USD 14,000 - 19,000; Full time

Job summary

Integra LifeSciences is seeking a Quality Inspector I to visually inspect labels, pids, and pouches, sampling and recording data, and making inspection-based decisions to ensure packaging and production quality. The role emphasizes GMP adherence, training of new inspectors, and flexibility to shift across stations as needed.

The position is 2nd shift (Mon-Fri, 1:30pm to 10pm) with responsibilities including use of gauges, calipers, and inspection equipment in a regulated manufacturing

Qualifications

• High School graduate or equivalent.
• One year experience in a similar FDA-regulated environment.
• Driver’s license on heavy vehicles highly preferred.
• Knowledge of basic math concepts, graph interpretation, and use of procedure, 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.

Responsibilities

• Inspect labels, pids and pouches visually to approve packing operations or other operations.
• Obtain samples, inspect samples to specifications, and record inspection data.
• Make accept/reject decisions based on inspection findings with respect to specifications.
• Follow quality control procedures and assist with rework as needed.
• Assist in training of new QA Inspectors.
• Maintain GMP/Quality Manual reinforcement and conduct spot audits.
• Set up and perform destructive and non-destructive tests as required.
• Maintain quality control records, blueprints, and documentation in orderly files.
• Ensure equipment calibration is up to date and report discrepancies.
• Follow clean room rules and wear required PPE.
• Work on priority orders to meet production schedules.

Skills

Quality inspection

GMP knowledge

Dimensional inspection

English reading

Safety compliance

Education

High School Diploma

Tools

Optical comparator

Micrometer

Calipers

Go/no-go gauges

Measurement instruments

Job description

Changing 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 I will Inspect labels, pid’s and pouches visually to approve packing operations or other operations. The successful candidate will obtain samples, inspect samples to specifications, record inspection data and makes accept/reject decisions based oninspection findings with respect to specifications.

This is a 2nd Shift role and the hours are Monday to Friday from 1:30pm tp 10pm.

Other Qualifications will also be required:

• Verifies dimensions, cavity measures, pressure, and other specifications of products, using measuring gauges and testing equipment such as optical comparator, micrometer, calipers, go-no-go gauges, pin gauges, microscope, air pressure gauges, and other testing instruments.
• Follows quality controlsinspection criteria in order to releaseacceptablelots to store or reject lots prior operations for re-work.
• Reads written specifications, drawings, and procedures such as the Quality Control Inspection Procedures.
• Fill quality control records, information on shop orders, and maintains other control reports and documentation.
• Assists intraining 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 material incoming inspection area.
• Sets up and performs destructive and non-destructive test on material, parts, or product to measure performance, material characteristics, etc.
• Maintains quality control records, blueprints, procedures, andother 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 are adequately calibrated and informsSupervisor of any discrepancy.
• Assures raw material or products released to stores or for sterilization fulfillquality 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 workstations. This applies to all area where safety shies area required.
• Maintains control of raw material quarantine area and printed materials, and discrepantmaterials in store.
• Works on priority orderswhenreleased before others to assurecompliance with productions schedules.

Qualifications

• High Schoolgraduate or equivalent.
• One (1) year experience in a similar position in an FDAregulated manufacturing environment preferred.
• Driver’s license on heavy vehicles highly preferred.
• Knowledge of basic math concepts, graph interpretation, and use of procedure, andinspection methods.
• Knowledge of statistical process control techniques.
• Ability to read, understand drawings and written documents in English.
• Ability to workusing testing instruments and manual equipment.
• Ability to be in a standing position for longperiods of time.

Salary Pay Range:

$10.50 - $13.46 USD Hourly

Our 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.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you’d like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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