Principal Quality Engineering Technician

Johnson & Johnson; Chihuahua; Presencial; MXN 719,000 - 1,080,000; Jornada completa

Descripción de la vacante

A leading healthcare company in Ciudad Juárez is seeking a Principal Quality Engineering Technician. This role involves supporting quality processes, training associates, and maintaining compliance with safety and quality standards. Candidates should have a minimum of a High School diploma and be pursuing an Engineering degree, along with 6 to 8 years of related experience. Preferred qualifications include bilingual proficiency and knowledge of GMP/ISO standards. This is an opportunity to contribute to innovative healthcare solutions.

Formación

• A minimum of High School Diploma and Engineering Bachelor's Degree complete or in progress.
• From 6 to 8 years related experience or pursuing an Engineering Bachelor’s Degree.
• Knowledge of GMP/ISO preferred.

Responsabilidades

• Provides training to associates/QA technicians and peers.
• Generates Non-conformances records in quality systems.
• Performs data collection and analysis for quality metrics.
• Assists Quality Engineers in line support and quality issues.
• Participates in continuous improvement activities.

Conocimientos

Bilingual: English/Spanish

Problem Solving

Quality Control (QC)

Report Writing

Teamwork

Educación

High School Diploma

Engineering Bachelor's Degree

Herramientas

ERP

ADAPTIV

PLM

Descripción del empleo

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: Ciudad Juarez, Chihuahua, Mexico

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.

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

Position Overview

We are searching for the best talent for Principal Quality Engineering Technician to be in Ciudad Juárez, Planta Independencia.

Purpose

• The quality engineering technician provides an active support to BCPs and validations.
• The quality engineering technician may supervise FG quality tech and raw material inspection tech.

Responsibilities

• Provides training as required to associates/QA technicians and peers in areas such as manufacturing processes, systems applications, measurement equipment, product complaints, and other as needed
• Generates Non-conformances records in applicable quality information system, as needed
• Performs verification of activities already completed under non-conformance reports
• Assists or executes failure investigations of non-conformances, audit findings, CAPAs, and other as indicated
• Knowledge in Quality Engineering tools such as measurement system analysis, basic statistics analysis and other as required.
• Performs data collection and analysis, creates and distributes reports for quality metrics, initiatives, and/or plant scorecards.
• Assist Quality Engineer in line support or per given experience own line support, including the processing of change orders on Documentation control system.
• Assist Quality Engineers in driving control plan effectiveness in the mfg lines.
• Act as a liaison to manufacturing for quality related issues, as designated.
• Maintain control of protocol related materials, ensuring the applicable controls (physical and electronic) are in place and ensuring parties are notified according to Ethicon procedures.
• Follows up with the protocol owners for the disposition of protocol materials.
• Generates and controls the applicable forms (QA to QA forms) for the transfer of protocol or nonconformance materials between Ethicon sites.
• Ensures the environmental / microbiology testing is executed according to the plan; samples are timely collected and submitted for testing according to Ethicon procedures.
• Follows J&J and Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices & Records Cleanout.
• Maintains, and provides information such as quality records from the company's quality information systems
• May act as an administrator of local quality information systems
• Participate in the development of new quality information system applications and processes
• Responsible in complying with Good Manufacturing Practices (GMPs), Regulations, International Standards, Environmental, and Health Policies
• Follows all company safety policies and other safety precautions within the work area
• Ensures compliance with safety policies and procedures
• Ensures compliance with Environmental Management System (EMS) responsibilities
• Ensure compliance with Quality systems policies and procedures
• Support protocol and execution of Test Method validation and/or Equipment validation.
• Performs Device History Records review and product release (including sterilization information as delegate). These activities require previous training on the applicable procedures.
• Verifies that information for rejected material is correctly identified and entered in nonconforming system as material is segregated.
• Controls non-conforming components returned from the production floor.
• Responsible for tagging material, verify material on hold status in applicable system, logging material in cage, and updating database.
• Witness of the appropriate destruction of non-conforming material following the applicable procedures.
• Help maintain a document retention system for the Juarez facility.
• Coordinates and actively participates on quarterly quality communication meetings
• Participates on departmental and company continuous improvement activities on Kaizen blitz, Kaizen or Green belt certification projects.
• Provide coaching and support to quality technician on yellow and orange belt projects.
• Participate in Test Method and Equipment validations.
• Perform change order for document revision as applicable.
• Assure that Bioburden, Dose Audit, In Vitro samples are segregate and send to laboratory.
• Tracking Laboratory samples and results.
• Provide support during External and Internal Audits (e.g.: document retrieval, consultation, etc.)
• Responsible for communicating business related issues or opportunities to next management level
• 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
• 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

Education

• American Society for Quality: CQIA (Certified as Quality Improvement Associate); CQA (Certified as Quality Auditor); (Process Excellence - Green Belt) Preferred
• A minimum of High School Diploma and Engineering Bachelor’s Degree complete or in progress.
• Bilingual: English/Spanish

Job Experience

• From 6 to 8 years related experience.
• Or currently pursuing an Engineering Bachelor’s Degree with half of School credits completion or recently completed preferred.

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

• Bilingual: English/ Spanish preferred.
• GMP/ ISO knowledge preferred.
• PC Literacy: proficient in word processing, spreadsheet, presentation, database applications required.
• Knowledge of Ethicon electronic systems (ERP, ADAPTIV, PLM) preferred.

Required Skills

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy

Preferred Skills

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy