Quality Inspector 1

INTEGRA CI INC

Añasco (PR)

On-site

USD 14,000 - 19,000

Full time

14 days+

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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
401(k) plan

Job summary

Integra LifeSciences is seeking a QA Inspector to visually inspect labels, products, and packaging in a FDA-regulated manufacturing environment. You will sample, inspect to drawings and specs, and record data to determine accept/reject decisions.

The role requires reading English documentation, using precision gauges, and maintaining QC records. Training new inspectors and supporting GMP goals are part of the job.

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.
  • Ability to be in a standing position for long periods of time.

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, go-no-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.
  • Sets 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

Attention to detail
Reading drawings
Reading specifications
Mathematical concepts
English reading

Education

High School diploma

Tools

Measuring gauges
Micrometers
Calipers
Go/no-go gauges
Optical comparator

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To 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, go-no-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.
  • Sets 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 Experience
  • 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: $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 careers@integralife.com.

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating - because the need is so urgent. You’ll be challenged - and supported - by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.

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