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Staff Process Quality Lead
hace 2 semanas
At
Johnson & Johnson , the largest healthcare company in the world, we come together for one purpose: to transform the history of health in 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 Move Could Mean Our Next Breakthrough.
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are changing the trajectory of human health,
YOU CAN TOO .
We are searching for the best talent for STAFF EH&S ENGINEER to be in Juarez
Purpose:
The Process Quality Lead position is established to enhance the Quality activities on the business unit, such as nonconformances, complaints, attend internal and external audits, audit observations resolution, quality indicators, escalation processes, CAPAs, DRB, PQSS and any quality issue affecting the business unit - Promote Quality Culture in Operations and Lead & engage strategies for risk management
You will be responsible for:
Develop and supervise effective defect tracking mechanisms and coordinate improvement actions.
- Lead efforts and projects to improve quality performance for the Business Unit, including In-Process Reporting, Software Upgrades to systems, etc.
- Lead quality system improvements, which result from internal audits, QLT, and Quality Board Issues, as required.
- Responsible for the appropriate execution of Quality Assurance test methods and inspections procedures of raw material, work in progress and finished product for the Business Unit.
- Establish and maintain programs, procedures and controls ensuring that product and raw materials are manufactured and controlled as per established procedures, specifications, medical device regulations, sterilization guidelines, and ISO standards.
- Support cost savings opportunities that work toward achieving the objectives of the Business Unit.
- Responsible for ensuring compliance with procedures for all nonconforming product and raw materials applicable to the Business Unit.
- Support projects and new product introductions by establishing key checkpoints for new products and processes.
- Ensure compliance with company policies and procedures.
- Promote the use of quality metrics and performance data to drive improvements.
- Support efforts in the use of Process Excellence tools to enhance analytical thinking and problemsolving techniques.
- In depth knowledge and analysis of voice of the customer (product complaints) and lead process improvements in collaboration with Engineering and Manufacturing to reduce or eliminate Product Complaints.
- Active participant in CAPA council boards (plant and franchise) and Management Review to identify and lead process improvements to reduce or eliminate complaints
Qualifications:
Qualifications and requirements:
Experience in Medical Device Industry preferred
- A Minimum of BS in Engineering
- CQE (ASQ) Certified, preferred
- Certification in Lean Manufacturing or Six Sigma is preferred.
- Generally, requires 68 years related experience.
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