Quality Operations Lead

hace 6 días

Ciudad Juarez, México Johnson & Johnson A tiempo completo

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

We are searching for the best talent for **QUALITY OPERATIONS LEAD **to be in **Juarez plant Salvarcar.
**PURPOSE**:
Plans, coordinates, and directs the quality assurance programs designed to ensure the continuous production consistent with the established standards through the following responsibilities, either personally or through his/her subordinates.

**DUTIES & RESPONSIBILITIES**
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Business Improvement
- Leads or support quality improvement initiatives, such as the characterization of processes and products that leads to continuous improvements / cost.
- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
- Performs benchmarking to develop more effective methods to improve quality.
- Establishes and formulates the quality metrics to maintain the quality assurance objectives and alignment with the objectives of the plant.
- Supports the development of quality engineering and the compliance with the quality with the adequate abilities for the introduction of new products and product life cycle management.
- Promotes and supports the implementation of quality, product, and process improvement projects.
- Revises and approves Engineering Change Orders (ECOs).
- Evaluation, monitoring and analysis of the quality costs to maintain a quality system according to the medical industry standards.

Compliance / Regulatory
- Revises / analyzes if the current products and processes (including performed actions or decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.
- Leads the preparations activities for regulatory agencies audits, including the active participation as “SME” or “Escort” (for example: FDA, JJRC, BSI, etc.).
- Revises and approves the answers to internal and external audit observations ton ensure the compliance with the internal procedures and applicable regulations.
- Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems.
- Ensures the performance of periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the results of the audits of the area to ensure that the corrective and preventive actions are adequate.

Finances
- Defines, monitors and administers the central budget of the department/cost.

New Products / Process Introduction
- Collaborates with NPI and with the operations and engineering departments to develop, conduct and approve validation strategies of products and processes.

Product Quality, Control and Disposition and Performance Standards
- Directs and attends to Revision meetings of NCs as a member of MRB.
- Revises and approves 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 applies.
- Provides direction and assigns resources for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level.

Product Grading / Process
- Revises and approves process validation strategies.
- Ensures the realization of periodical maintenance and revision of the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
- Approves the revision and maintenance of PFMEAs, Quality control Plans, Process Instructions and additional manufacturing documents.
- Provides support to the development and proper implementation of process monitoring and control methods consistent with the process/product risk level.
- Promotes the use of innovative tools for the timely detection and mitigation of risks. Determines the effectiveness of these techniques in the improvements previously implemented.
- Responsible and owner of the risk assessment evaluation including the realization, documentation, revision, maintenance of current risk and documentation of the risk assessment such as FMEA of the process given to changes in the product/process.

Strategy
- Collaborates with the quality leaders to identify the required quality engineering skills and

competences that allow the execution of the strategic vision.
- Performs the strategic planning with the site leaders and with the product engineering team.

Works in t

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