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

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/. 

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

JOB SUMMARY

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

DUTIES & RESPONSIBILITIES

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

• Supports 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.
• 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.
• Primary coordinator for APMER related items such as request, documentation, closure, and transactions.
• Support periodic review activities related to Quality Operations.
• Perform Cycle Review activities.
• Perform Operator certification for defect inspections. 
• Conduct failure investigations, root cause analysis, and product complaint investigations.
• Provide BOP, Internal audit, and external audit support.
• Read and interpret drawings, QCIC's and test methods.
• Develop, prepare, and report technical information to management to identify, segregate and disposition product through the nonconforming system.
• Support handling and disposal activities for scrap, obsolete, or unusable materials
  • 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.

EXPERIENCE AND EDUCATION

• High School Education or GED is required, bachelor’s degree preferred.
• Minimum of two (2) years of experience in a manufacturing environment is required.
• Ability to perform duties in accordance with policies and procedures.
• Experience in the Medical Device industry or medical field preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• 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 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 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

#LI-Onsite 

 

 

Required Skills:

Manufacturing, Medical Device Assembly, Medical Device Manufacturing, Medical Device Production, Medical Equipment Manufacturing

 

 

Preferred Skills:

EtQ Reliance, JDE OneWorld, SAP MES