**Job Function**:
Quality
**Job Sub Function**:
Quality Assurance
**Job Category**:
Professional
**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, Mexico, Ciudad Juarez, 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 Quality Engineer I to be in Cd. Juarez, Chih. at Plant Salvarcar**
**Purpose**:
The Quality Engineer I plans, provides support to engineering projects or studies. Applies engineering principles and practices within the assigned areas. Can coordinate and direct personnel activities of technical support and is responsible for the technical development of the personnel assigned. The quality engineer I will use quality engineering tools and practices for the effective and efficient development of transfers and product / processes maintenance in the complete life cycle of the product. The holder of this position will also use his/her abilities of investigation and problem resolution to improve and maintain the products / processes that are aligned with the quality and global business vision. He/she will use the appropriate risk management to prevent unanticipated failure modes and to improve the quality of the processes. This person will provide support to the business processes.
**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 problem resolution techniques such as (PCDA), Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
**Compliance / Regulatory**
- Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during scheduled internal and external audits. - Participates in quality readiness and in 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. Establishes and properly maintains the required documentation of quality engineering activities and/or quality systems.
- Performs periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audits results of the area ton ensure that the corrective and preventive actions are adequate.
**Product quality, Control and Disposition and Performance Standards**
- Ensures Non -Conformant product or components are quarantined following applicable procedures.
- Conducts or supports investigations, bounding, documentation, revision and approval of the nonconformities (NCs), including the corresponding NC completion follow up, preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applies.
- Analyzes / revises the effectiveness of preventive and corrective actions.
**Product Grading / Process**
- Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.
- Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
- Provides support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.
- Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level.
- Evaluates and interprets common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits.
- Evaluates the needs of risk mitigation techniques given the classification of the product, potential types of defects, defect frequency, severity, risk to the patient, process capacity, process control, etc.
- Determines the effectiveness of these techniques in the previously implemented improvements.
- Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and risk analysis documentation such as FMEA of the process given the changes in the product/process.
**Strategic**
- Collaborates with other quality leaders to ident