site quality lead wch juarez

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Juarez, Chihuahua, Mexico

Job Description:

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.

Your unique talents will help patients on their journey to wellness. Learn more at

About Surgery

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 surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at

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

We are searching for the best talent for SITE QUALITY LEAD WCH JUAREZ

Purpose:

The Site Quality Lead WCH Juarez is responsible for all Quality Operations activities for the site assuring compliance to the Quality Management System and acting as the management Representative for the site, this position reports to the Senior Director Ethicon Supply Chain Quality WCH and Biosurgery. Below list of Duties and Responsibilities.

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:

· Acts as Management Representative for site.

· Responsible for developing and executing strategy to drive supply reliability, improvements in manufacturing capabilities, adherence to financial targets, and design (product and process) reliability of new and existing products.

· Scope of work includes multiple business units under one quality system

· Oversees the development of policies and procedures which affect operational and compliance status in alignment with franchise and enterprise where appropriate.

· Assures compliance with regulatory requirements for the countries in which the site's products are sold (FDA 21CFR Part 820 & Part 4, ISO13485:2016, etc.).

· Develops a fiscal budget to support quality assurance, supply reliability and compliance objectives

· Forecasts and manages headcount, capital, and other resource needs.

· Coordinates and oversees activities related to internal audits to assure compliance with company, state, federal, and international standards. Ensures that the site is in a constant state of readiness for internal or external audits. Acts as host during external audits.

· Monitors and supports supplier quality performance to ensure that the end-to-end supply chain meets Quality assurance objectives.

· Facilitates the development and training of Quality and Manufacturing personnel.

· Manages (directly or through indirect influence) an extended quality and compliance organization of greater than 100 employees from Quality laboratories, Receiving Inspection, Final Release, Manufacturing Quality operations, Documentation Control, Training, and Compliance audits for manufacturing sites.

· Responsible for communicating business related issues via defined escalation process or opportunities to next management level.

· Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all equipment and resources needed to do their job are available and in good condition.

· Responsible for ensuring compliance with all Federal, State, local and Company regulations, policies, and procedures.

· Performs other duties assigned as needed.

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

· Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

· 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

Qualifications / Requirements:

·10 or more years of related experience in manufacturing, quality or technical fields and/or training; or equivalent combination of education and experience.

· A minimum of Bachelor of Science degree or equivalent in a related field.

· Master's degree in an applicable field of study (recommended).

· Understanding of medical device regulations. Work experience in medical device industry highly preferred. Work experience in regulated healthcare industry preferred.

· Ability to read, analyze and interpret the most complex documents.

· Ability to respond effectively to sensitive inquiries or complaints.

· Ability to manage effective communication of controversial and/or complex topics with multiple audiences, including direct reports, peers and managers as well as communication upward through senior management.

· Ability to apply analytical techniques to identify issues and opportunities.

· 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 manage with several abstract and concrete variables.

· Ability to use PC's and associated software.

· Ability to effectively manage communication with representatives of various government agencies.

Required Skills:

Preferred Skills:

Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning

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