Quality Assurance Technician

Johnson & Johnson•San Lorenzo, PR

2d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Control Job Category: Business Enablement/Support All Job Posting Locations: San Lorenzo, Puerto Rico, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Quality Assurance Technician. Purpose: Reports to the Quality Team Leader or Designee, with the objective of maintaining high Quality Standards for Product Quality Control and operations compliance with regulatory requirements. Conducts routine physical inspection procedure to in-process material, as well as finished goods, as needed. Inspection involves the use of skilled specifications and established quality standards. Performs audits to ensure product and processes comply with requirements.

Requirements

Associate’s degree is required, degree in a science or technical field is preferred; with a minimum of four (4) years of experience in a regulated industry and at least two (2) years in Quality or related roles is required.
Basic Knowledge of computers is preferred.
Knowledge of QSR's and ISO Standards is required.
Basic English communication skills is preferred.
Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

Responsibilities

Maintains high Quality Standards for Product Quality Control and operations compliance with regulatory requirements.
Conducts routine physical inspection to in process, and finished goods samples as needed.
Performs product and process audits.
Performs visual and dimensional inspection according to current specifications/procedures.
Review and complete transactions such as, but not limited to, batch records review, Sterilization Certificates of Processing and appropriate records retention in Manufacturing and Quality Systems to release Finished Goods products.
Use LIMS and ERP System to document the inspection results and disposition to product prior to release.
Work with different Sterilization Suppliers and assists as required.
Handle efforts among Sterilization Plants and the Site.
Generate Certificate of Analysis (COA) as per Client’s and other Plants Requests
Notify any product or process non-conformance and escalates as appropriate.
Inspects, tests and/or evaluates the quality of products.
Segregates and inspects Finished Goods samples and Retain Samples according to the requirements.
Delivers samples to Finished Goods QA Lab.
Performs data analysis and executes final disposition of the material as required.