Quality Assurance Technician

Johnson & Johnson MedTech; San Lorenzo (CA); On-site; USD 42,000 - 56,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Assurance Technician to uphold high quality standards for product quality control and regulatory compliance.

The role reports to the Quality Team Leader and supports inspections, audits, data analysis, and documentation across finished goods and in-process materials. A high school diploma or technical degree is required, with QA experience preferred and bilingual English/Spanish communication capabilities.

Qualifications

• High School Diploma and one year of experience in a regulated industry required; or a Bachelor's Degree in a technical or science field.
• One year of quality assurance experience is preferred.
• Knowledge of QSRs and ISO Standards is required.
• PC literacy including MS Office and related software is required.
• Verbal and written English and Spanish communication skills are required.
• Overtime and multiple shift availability, including weekends and holidays, may be required.

Responsibilities

• Maintains high quality standards for product quality control and regulatory compliance.
• Performs routine inspection, testing, or evaluation of in-process materials and finished goods.
• Performs product and process audits.
• Notifies non-conformances and escalates as appropriate.
• Segregates and inspects finished goods samples; delivers samples to QA Lab as needed.
• Performs data analysis and final disposition of materials.
• Reviews batch records and ensures retention per requirements.
• Maintains knowledge of procedures, specifications, and new regulations.
• Completes assigned trainings on time.
• Supports associates on defect awareness and specification requirements.

Skills

Attention to detail

Quality assurance

Regulatory compliance

Data analysis

Documentation

Communication skills

Teamwork

Problem solving

Shift work

Education

High School Diploma

Bachelor's degree in science/technical field

Job description

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

You Will Be Responsible For

• Maintains high Quality Standards for Product Quality Control and operations compliance with regulatory requirements.
• Conducts routine physical inspection, testing, or evaluation to ensure quality of products according to current specifications/procedures.
• Performs product and process audits.
• Notify any product or process non-conformance and escalates as appropriate.
• Segregates and inspects Finished Goods samples and Retain Samples according to the requirements. Delivers samples to Finished Goods QA Lab if needed.
• Performs data analysis and executes final disposition of the material as required.
• Performs batch records review accordingly with compliance requirements and complete record retention process.
• Maintain knowledge of all procedures, change to specifications and new regulations related to their areas of responsibility.
• Ensures on-time completion of assigned trainings.
• Support associates on defect awareness and specifications requirements.

Qualifications / Requirements

• High School Diploma and one (1) year of experience in a regulated industry is required; or Bachelor’s Degree in a technical or science field.
• One (1) year of Quality assurance experience is preferred.
• Knowledge of QSR's and ISO Standards is required.
• PC literacy including MS Office and use of other software and applications is required.
• Verbal and written communication skills in English and Spanish are required.
• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

Required Skills

Preferred Skills

Agility Jumps, Compliance Management, Curious Mindset, Customer Centricity, Detail-Oriented, Document Management, Factory Acceptance Test (FAT), Persistence and Tenacity, Process Oriented, Professional Ethics, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Regulatory Compliance, Technical Support