Quality Operations Technician

Regulatory Jobs; Irving (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Operations Technician to support quality assurance inspections and drive continuous improvement in production processes. The role emphasizes GMP, GDP, data integrity, and collaboration with cross-functional teams on manufacturing floors.

Responsibilities include contributing to CAPA/NC programs, assisting with data collection for quality metrics, and supporting audit activities and product disposition in the nonconforming system.

Qualifications

• High School Education or GED is required.
• Minimum of two (2) years of experience is required.
• Proficiency with ETQ, JDE, MES, MS Word and Excel is desired.
• Medical Device manufacturing experience is preferred.

Responsibilities

• Supports quality operations functions including CAPA/NC initiatives, on-the-floor quality presence, and GDP/Data Integrity practices.
• Assist with data collection for quality metrics and quality-improvement initiatives.
• Conduct failure investigations and root cause analysis.
• Perform data searches in MES, JDE, and EtQ and support NC processes and corrective actions.
• Provide support for internal and external audits and for finished goods release trace activities.

Skills

Attention to detail

Communication

Independent worker

Team collaboration

Education

High School Diploma or GED

Tools

ETQ

JDE

MES

MS Word

MS Excel

Minitab

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Quality Operations Technician.

Purpose: Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes and standards.

You will be responsible for:

• Supports v Quality Operation functions including: CAPA/NC initiatives, Quality “presence” on the manufacturing floors, and proactive GDP and Data Integrity.
• Assist with data collection for quality metrics, quality improvement initiatives, CAPAs, NCs, or Quality Systems.
• Conduct failure investigations and root cause analysis.
• Perform data searches and transactions within MES, JDE, and EtQ.
• Partner with QEs and business partners (and other NC “owners”) providing support with NC process, investigations, and/or corrective actions.
• Actively influence the team and other fellow workers as role model for Collaboration and Teamwork
• Provide BOP, Internal audit and external audit support.
• Read and interpret drawings, QCIC's and test methods and perform the tasks defined therein.
• Develop, prepare and report technical information to identify, segregate and disposition product through the nonconforming system.
• Support periodic review activities related to Quality Operations.
• Backup support for finished good release trace activities.
• Support quality improvement related projects
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), 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

Qualifications / Requirements:

• High School Education or GED is required.
• Minimum of two (2) years of experience is required.

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

• Professional certifications (CQAI, CQA or others) are desired.
• Green Belt Certification preferred.
• Project deployement experience is a plus.
• Previous experience in non-conformance investigations and root cause analysis desired.
• Attention to detail and robust documentation practices are required.
• Must be able to communicate training procedures, specifications, and procedures
• Must be able to work both independently and within cross-functional groups.
• Proficiency in ETQ, JDE, MES, MS Word and Excel is desired.
• Computer experience utilizing such programs as JDE, MS Word and MS Excel, Minitab for project initiatives and problem solving.
• Ability to interpret a variety of instructions furnished in written, oral diagram, or schedule form.
• Medical Device manufacturing experience is preferred.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Good Document Practice (GDP), Quality Operations