Quality Inspector II

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

Job summary

Integra LifeSciences is seeking a Quality Inspector II for the 2nd shift in Añasco, PR. You will inspect raw materials, WIP, and finished goods, recording data and making go/no-go decisions to ensure conformance with specifications.

The role requires using gauges and testing equipment, and may involve training new QA inspectors and supporting GMP efforts. Responsibilities include sampling, dimension verification, and adherence to QC procedures to release lots.

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, pids, 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.

Skills

Math concepts

Statistical process control

Reading drawings

In English reading/writing

Testing instruments handling

Education

High School diploma

Tools

Optical comparator

Micrometers

Calipers

Gono-go gauges

Pin gauges

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 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 informsSupervisor 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.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 LifeSciencesIntegra 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 VeteransIntegra 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] Agency SubmissionIntegra 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.Integra - Employer Branding from Integra LifeSciences on Vimeo