Ingeniero de Calidad Staff

Johnson & Johnson; Ciudad Juárez; Presencial; MXN 920,000 - 1,290,000; Jornada completa

Descripción de la vacante

A leading healthcare company is looking for a Staff Quality Engineer in Ciudad Juárez. The role focuses on implementing quality engineering practices to enhance product/process lifecycle management. The ideal candidate will possess a bachelor's degree in engineering, with 6-8 years of experience and strong problem-solving skills. Familiarity with Lean methodologies and statistical analysis is essential for success in this position.

Formación

• 6 to 8 years of work experience or demonstrated performance.
• Proficiency in English (oral and written).
• Advanced technical training in statistics and Lean methodologies.

Responsabilidades

• Plan or adapt new methods to control technical projects.
• Perform benchmarking to develop effective quality improvement methods.
• Establish quality metrics and indicators.
• Revise and approve engineering change orders (ECOs).
• Support product quality and compliance with regulations.

Conocimientos

Problem-solving

Risk management

Lean methodologies

Statistical analysis

Project leadership

Educación

Bachelor degree in engineering

Herramientas

Statistical software

Descripción del empleo

Overview

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 Details

Job Function: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Ciudad Juarez, Chihuahua, Mexico

Job Description: 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 Cardiovascular: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. 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 Staff Quality Engineer to be in Juarez, Chih.

Position Purpose

The Quality Engineer Staff plans or adapts the new methods or procedures to control or coordinate all the aspects of several projects at the same time and in the solution of the related technical projects. The engineer Staff is an emergent authority in a specific technical field, exercising a considerable freedom in the determination of the technical objectives of the assignments. The work results typically in the development of new or improved methods to reduce risks, equipment, materials, processes, products and technical methods. The Engineer Staff acts as a mentor for lower hierarchy personnel and provides advice to upper management about technical matters. The Quality Engineer Staff will use tools and quality engineering practices for the effective and efficient development of transfers and maintenance of products/processes in the whole life cycle of the product. The holder will use quality engineering principles and investigation skills for the resolution of complex problems associated to the manufacturing process at a local or franchise level, including Escalations. They will use risk management to prevent unforeseen failure modes and improve process capacity. This person will provide support to the business process and supervisor or direct technicians.

You will be responsible for

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

• Business Improvement: Revision/analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.
• Performs benchmarking to develop more effective methods to improve quality.
• Establishes the metrics that are the quality indicators.
• Provides support to the development of quality engineering and the compliance of the quality with the adequate abilities for the introduction of new products, and the management of the life cycle of the product.
• Revises and approves engineering change orders (ECOs).
• Establishes the categories of the quality costs and bases of the quality cost.

• Compliance / Regulatory: Revises/analyzes if current products and processes comply with regulations (QSRs, ISO 13485, etc.), including support during audits. Participates in preparation activities for interactions with regulatory agencies (FDA, JJRC, BSI, etc.). Responds to internal or external audit observations related to quality engineering. Maintains required documentation of quality assurance activities and quality systems. Performs periodic audits in the line to evaluate GMPs, production controls, lot segregation, and audits to the process; revises audit results to ensure adequate corrective and preventive actions.

• Finances: Controls and maintains the central budget of the department/cost.

• New Products / Process Introduction: Works with NPI and with manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies.

• Product Quality, Control and Disposition and Performance Standards: Directs and attends revision meetings of NCs as a member of the MRB. Conducts or supports investigations, documentation, revision and approval of non-conformities (NCs), CAPAs, customer complaints and escalation of quality problems. Responsible for identification of material, material segregation, defect classification, and day-to-day application in manufacturing. Analyzes the effectiveness of preventive and corrective actions. Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product. Provides support for resolving complex manufacturing process problems.

• Product Grading / Process: Revises, approves, executes IQ/OQ/PQ/TMV or software validation. Maintains CTQs in manufacturing processes and ensures continuous customer satisfaction. Develops and maintains measuring methods and PFMEAs, quality control plans, process instructions, and related manufacturing documents. Develops and implements process monitoring and control methods aligned with process risk. Evaluates causes of common vs special variation and defines process limits. Assesses risk mitigation needs due to product classification and potential defects. Owns risk assessment processes including FMEA updates due to product/process changes.

• Strategy: Collaborates with quality leaders to identify required quality engineering skills and competencies to execute the strategic vision.

• People: Provides supervision, mentoring, coaching, performance reviews, development plans and succession planning where applicable. Communicates business issues/opportunities to management. Ensures compliance with health, safety and environmental practices and company regulations; ensures resources are available and in good condition. Performs other duties as needed.

Qualifications / Requirements

• Bachelor degree in engineering (Mechanical, Electrical, Industrial or applicable science) or equivalent experience.
• 6 to 8 years of work experience or demonstrated performance.
• Proficiency with computer packages and ability to communicate in English (oral and written).
• Knowledge of product/process risk management (FDA and ISO regulations) preferred.
• Advanced technical training in statistics and Lean methodologies and Six Sigma (MSA, SPC, DOEs, reliability, etc.).
• Strong knowledge of statistical software; ability to visualize, graph data and present insights for decision making.
• Active problem-solving approach and solid judgment; demonstrated project leadership is desirable.
• Certifications such as CQA and CQE (preferred), CBA and Green Belt are a plus.