Senior Quality Operations Manager

hace 1 semana

Ciudad Juarez, México Johnson & Johnson A tiempo completo

**"Johnson & Johnson companies are equal opportunity employers"**
- At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.- Diversity & 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 Next Move Could Mean Our Next Breakthrough.**SENIOR QUALITY OPERATIONS MANAGER**

**JOB SUMMARY**

Plans, coordinates and directs the quality assurance programs designed to ensure the continuous production of products consistent with the standards established through the following responsibilities, whether personally or through his/her subordinates. At this level, the position has a mayor impact in the business results and typically, in the responsibility of the management of the group of professionals under his charge.

**If CSS Position**:This position will have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multipleproductplatforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology andSurgical and Non-SurgicalAesthetics.

**If CNV Juarez Position**: Might be designated as the site Management Representative

**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 supports quality improvement initiatives, such as characterization of process and products that lead to continuous improvement / cost.
- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
- Performs benchmarkingin order to develop more effective methods to improve the quality.
- Establishes and formulates the quality metrics to maintain the goals of quality assurance and alignment with the objectives of the plant.
- Supports the development of quality engineering and the compliance with the adequate skills for the introduction of new products, and management of the life cycle of the product.
- Promotes and supports the implementation of quality, product and process quality improvement.
- 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 actions or decisions performed) comply with the regulations, such as the QSRs, ISO 13485, etc.
- Leads preparation activities for audits by regulatory agencies, including the active participation as “SME” or “Escort” (e.g. FDA, JJRC, BSI, etc.).
- Revises and approves answers to internal or external audit observations to ensure the compliance with the internal processes and applicable regulations.
- Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
- Ensures the performance of the periodical audits of the line to be evaluated, GMPs, production controls, lot segregation, and process audits according to JJPS. Revises 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 Revision meetings of NCs as member of the 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 applicable.
- Provides direction and assign 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 performance of a 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 the PFMEAs, quality control plans, processes instructions, and additional manufacturing documents.
- Provides support in the development and proper implementati

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