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:

Irving, Texas, 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

We are searching for the best talent for QA Ops Engineering Tech to be in Irving, Texas.

SECTION 1: JOB SUMMARY

Responsible for conducting technical quality assurance inspections and using results to improve production processes and standards. This involves a variety of lab duties including following proper safety procedures and reading and interpreting drawings, quality control inspection procedures and test methods. Performs the defined tasks to complete inspection tests as described with precision and accuracy to assure optimum control of quality. Performs complex tests and analyses to assure that products comply with established specifications. Carries out difficult calculations and prepares documentation that shows the results of tests performed. Completes record of inspection results, acceptance, rejection and disposition. Enters data into log books or computer databases. Compiles data and prepares reports on findings.

SECTION 2: DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Ensure proper safety procedures and practices are utilized including maintenance of the work area, tools, and test equipment in a clean and safe condition.
• Read and interpret drawings, quality control inspection procedures and test methods to perform the defined tasks to perform inspection tests as described with precision and accuracy to assure optimum control of quality so that raw materials and/or finished products conform to Standard Operating Procedures, government regulations, and adheres to all Quality System Requirements (QSR).
• Ability to conduct testing in at least two different QC Lab Work Centers. Sustains training and performs testing periodic within multiple lab work centers to maintain resource flexibility.
• Perform lab testing according to assigned lab work center, which may include turbidity, appearance, peel strength, tensile, joint and leak tests, material measurements, environmental monitoring, sterility, bioburden, LAL testing, or dentification of microorganisms
• Assist in the execution of technical protocols.
• Handles shifting priorities for self and others based on business demands.
• Assists in data collection and analysis of quality metrics for the departments.
• Ability to perform basic maintenance and diagnose problems for inspection equipment.
• Investigate and determine potential sources of failures and provide and implement solutions to prevent failures.
• Generate updates to documents and create new documents as required.
• Conduct training of new associates to the area.
• Ability to manage one or two small projects independently.
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs).
  • Responsible for communicating business related issues or opportunities to next management level
  • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed

SECTION 3: EXPERIENCE AND EDUCATION

• A minimum of a high school diploma is required. (prefer coursework to include mathematics, Algebra I and Algebra II).
• A minimum of six (6) years lab experience, or equivalent knowledge and skills necessary to satisfactorily perform the position responsibilities is required.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Demonstrates ability to work in a fast-paced diverse team environment and individuals while taking personal responsibility for decisions and driving results.
• Communicate effectively with co-workers and management on results and status of testing or projects.
• Basic math skills, with the ability to add, subtract, multiply, divide, and compute percentages and work with decimals and fractions is required.
• Ability to effectively use Microsoft office and other lab software to produce graphs, charts, and perform basic statistical analysis on test data is required.
• Experience working in FDA and regulatory environment is preferred.
• Testing experience is preferred. Experience with inspection equipment (i.e. Instron) is preferred.
• Ability to give and receive constructive and candid feedback.
• Ability to manage assigned work independently is required.
• Ability to analyze and interpret data and resolve problems related to inspections situations.
• Attention to detail and documentation practices is required.
• Lab Testing includes more technique and skill levels, such as dilution schemes and preparation of chemical solutions per standard formulas.
• Depending on assigned lab work center, ability to use test equipment including but not limited to material testing systems, penetrometers, balance, calipers, gauges, autoclave, water bath, pH meter, balance, and data logger systems.

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 ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.