Staff Quality Engineer (Ciudad Juárez)

Staff Quality Engineer (Ciudad Juárez)

13 ago
|
Johnson & Johnson
|
Ciudad Juárez

13 ago

Johnson & Johnson

Ciudad Juárez

**Job Function**:
Supply Chain Engineering
**Job Sub Function**:
Quality Engineering
**Job Category**:
Scientific/Technology
**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 Cardiovascular**
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 Cardiovascular? Ready to join a team that’s reimagining how we heal? 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.
**We are searching for the best talent for STAFF QUALITY ENGINEER to be in Ciudad Juarez.**
**Purpose**:
Constructs critical Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.
Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
Oversees, under general direction, capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.
Confers with team members on process validations for current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.




Assist in establishing ongoing training of Quality Engineering Technicians, supporting and enforcing site-specific safety and industrial hygiene requirements.
Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
Coaches more junior colleagues in techniques, processes, and responsibilities.
Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
**You will be responsible for**:
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 the engineering change orders. (ECOs).
- Establishes the categories of the quality costs and bases of the quality cost.
Compliance / Regulatory
- Revises / analyzes if the current products and processes (including actions or decisions performed)



comply with the regulations, such as the QSRs, ISO 13485, etc, including providing support during internal and external audits.
- Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
- Responds to internal or external audit observations related to the function of quality engineering.
- Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
- Performs periodical audits in the line to evaluate GMPs, production controls, lot segregation and audits to the process according to JJPS. Revises the audit results of the area to ensure that the corrective and preventive actions are adequate.
Finances
- Controls and maintains the central budget of the department/cost.
New Products / Process Introduction
- Works with NPI and with the 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 to Revision meetings of NCs as member of the MRB.
- Conducts or supports the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and Escalation of quality problems when applicable.
- Analyzes/revises the effectiveness of the preventive and corrective actions.
- Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
- Provides support for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level.
Product Grading / Process
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📌 Staff Quality Engineer (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez

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