Site Quality Lead Jobs

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered

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 in this for life.

We are changing the trajectory of human health, YOU CAN TOO.

Please visit https://www.jnjmedicaldevices.com/es-419 for more information.

Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster has pioneered innovative technological advancements for more than 30 years. Some might call this quite a heritage. At Biosense Webster, we say it's just the beginning. For more information, visit www.biosensewebster.com

We are searching for the best talent for SITE QUALITY LEAD to be in CIUDAD JUAREZ.

PURPOSE:

Develops, implementsand coordinates quality assurance programs and activities such as quality operations, product release, CAPA, non-conformancesystem and quality laboratories to ensure that released products are safe, effective and of the highest quality and ensures compliance to regulatory requirements and applicable standards.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 multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics.

YOU WILL BE RESPONSIBLE FOR:

• Might be designated as Management Representative and/or Head of Quality Make for the Site by the Operating Company.

• Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, manufacturing problems and quality systems indicators.

•Oversees the development of policies and procedures which affect operational and compliance status.•Assures compliance of the Quality System with all regulatory requirements and applicable standards.

• Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.

• Evaluates contents of reports on product assurance from department heads and confers with top management personnel in preparation to formulating a fiscal budget.

• Responsible along with Regulatory compliance to assure compliance through the laws and applicable standards during internal and external audit programs.

• Oversees the evaluation of and suggests alternative methods and procedures in solving problems.

• Partners with others to define needs for standardization and ensures the compliance level meets standard operating procedures and applicable standards and regulations.

• Organizes, plans, leads and manages quality related projects in alignment with company goals Facilitates the development and training of immediate staff.

• Prioritizes use of staff resources based on global project team input.

• Forecasts headcount and resource needs based on these priorities.

• Estimates and Oversees staff.

• Responsible for communicating business related issues or opportunities to next management level

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

• Bachelor of Science degree or equivalent in a related field

• 15 or more years of related experience and/or training; or equivalent combination of education and experience

• Knowledge and ability to interpret laws and applicable standards according to product type.

• Ability to read, analyze and interpret the most complex documents

• Ability to respond effectively to the most sensitive inquiries or complaints

• Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors

• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis

• Ability to define problems, collect data, establish facts, and draw valid conclusions

• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

• Ability to use PC's and associated software

• Ability to effectively deal with representative of various government agencies

• Ability to effectively deal with a variety of conflicting issues and diplomatically solves those issues.

• Clear understanding of applicable standards and regulations

• A Master’s degree in an applicable field of study would is preferred