Johnson & Johnson companies are equal opportunity employers.
SR DIRECTOR QUALITY ASSURANCE-8653140414
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is currently recruiting a Sr. Director of Quality Assurance in the Bay Area, CA.
For more than 50 years, Cordis has pioneered less invasive treatments for cardiovascular disease. Hundreds of millions of people globally have some type of cardiovascular disease with only a small percentage actually ever being diagnosed. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis one of the world's leading developer and manufacturer of breakthrough products for interventional medicine. Given this significant business need and tremendous opportunity to help our customers around the world and the patients that they treat every day, we are searching for highly talented undergraduate students to join us on our journey to lead the fight against Cardiovascular Disease.
We are looking for leaders to bring health care solutions to our customers and communities in virtually every corner of the world…leaders to nurture and inspire others…leaders who are committed to making a difference…individuals with strong character and proven competencies needed to become tomorrow's leaders in a global environment. Our business principles are embodied in Our Credo, a respected, legendary value statement that has guided our Family of Companies.
Develops, implements, and coordinates product assurance programs to prevent or eliminate defects in new or existing products to ensure that all released products are safe, effective and of the highest quality and ensures compliance to all regulatory requirements by performing the following duties personally or through subordinate supervisors.
Provide Quality leadership, strategy and technical guidance. Responsible for developing business solutions for manufacturing, new product development, and process improvement. Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program. Conducts management meetings with department heads to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
Provide technical guidance and leadership to support field complaints and production problems. Brings those in need of corrective action to upper management's attention. Assures implementation of corrective action as required, and assures compliance to procedures and regulations by requesting and monitoring corrective actions as necessary. Responsible for ensuring personal and company compliance with all Federal, State, local and company. regulations, policies and procedures for Health, Safety and Environmental compliance
Ensure that a suitable and effective Quality System is established and maintained in harmony with the Franchise Quality System and in accordance with applicable standards and regulations, and report on the performance of the Quality System to Business Unit Management. Ensure that an effective organization is established and maintained to support and implement the overall Cordis Quality System. Serves as the Management Representative for the Cordis Franchise . Represents the company during compliance inspections by United States regulatory agencies, Notified Body and foreign governments for compliance inspections, as required.
May act in the capacity of designated official correspondent with the FDA in matters of enforcement actions and related inspections. Formal designee as the Management Representative of the Quality System for Cordis. Responsible for ensuring management reviews of the quality system are conducted. Maintains up-to-date knowledge of global medical device regulations and standards affecting Operating Group’s companies product development, manufacturing and distribution activities. Provides updates to company, franchise management and Johnson & Johnson corporate quality regarding compliance status and performance of the companies within the Operating group relating to quality. Plans and directs resources and activities of the quality and compliance functions.
Directs implementation of product recalls, market withdrawals and safety alerts in collaboration with Regulatory Affairs for international involvement.Manages subordinates at multiple sites and at the different companies within the Operating Group, in areas of quality and compliance and is responsible for the overall direction, coordination and evaluation of these sites/companies. Provides consultation to all functional management groups by providing compliance input for new projects, including but not limited to, product development, manufacturing and distribution. Directs implementation of new Quality & Compliance programs required by regulations or Johnson & Johnson directives.
Establishes and maintains Quality programs, procedures, and controls between core teams. Ensures that performance and quality of products conform to established company and regulatory standards. Manages all aspects of product sterilization from validation through product release. Advises staff to help meet established schedules or resolve technical or operational problems. Formulates and maintains quality objectives and coordinates objectives with pre-production and production procedures in cooperation with other manufacturing managers to maximize product reliability and minimize costs. Maintains an up to date knowledge in the techniques of quality and in the company products and process technologies.
Manages customer satisfaction process including applicable global MDR/vigilance reporting activities. Oversees compliance, inspections, quality engineering, quality systems, inspectors, document control, microbiology, customer satisfaction, and labeling and product release functions. Acts in the capacity of designated Official Correspondent with the Food and Drug Administration and State of California in matters of establishment registrations and related matters. Estimates and administers budget schedules and performance standards.
Active representative on the Cordis Management Board. Accountable for supporting the MD&D Quality Management Systems Working Group. The working group assures that the Quality Systems in MD&D converge toward the JJQS vision of one quality system. Responsible for providing Business Quality input to the development of the architecture of MD&D quality systems. Will assure that the Quality Systems goals of their Business are aligned with those of JJQS. Will collaborate with members of the Working Group to support agreed to initiatives of this team.
Qualifications
Bachelor’s degree in engineering and/or scientific discipline or equivalent plus minimum of 12 years experience as a Quality Professional in the Medical Device industry required. Master's degree in applicable field preferred.
Minimum of 5 years prior supervisory and a demonstrated ability to effectively train and mentor a diverse array of employees at all levels of the organization is required.
The ability to analyze and interpret the most complex documents and the ability to define problems, collect data, establish facts, and draw valid conclusions is required. The ability to respond effectively to the most sensitive inquiries or complaints. The ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Knowledge of mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis is required. Demonstrated ability to build and develop a strong management team that is accountable, delivers results, meets commitments is required. Demonstrated ability to build a strong management team across multiple site locations is required.
Must be able to travel extensively domestically and internationally.
Superior verbal and written communication skills and ability to effectively communicate with internal and external personnel at all levels of the organization. Ability to make solid decisions that will effectively support the business and company policies.
In-depth knowledge and practical application of quality and manufacturing systems and processes and relevant regulations, i.e. ISO 13485, FDA’s GMP and QSR requirements for medical devices is required. Superior regulatory, technical and business knowledge to develop operational strategies for continued quality assurance is required. The ability to develop long-term strategies and implement corresponding performance standards is required. Demonstrated analytical and problem solving skills.
Demonstrated working knowledge and experience in managing third party inspections and negotiating with 3rd parties on compliance issues is required. Excellent management skills required. Well-developed Influencing and negotiation skills required. Ability to effectively train and mentor a diverse array of employees at all levels of the organization. CQM or CQE certification from the American Society for Quality (ASQ) or equivalent is a plus. Skilled at preparing executive briefings and broad communications. Strong business and financial acumen. Highest ethical standards and integrity.
The ability to influence and negotiate at all levels of management and with business partners, both internal and external, is required.
This position is located in Freemont, CA and requires 30% travel national, may require occasional international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
SR DIRECTOR QUALITY ASSURANCE-8653140414
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is currently recruiting a Sr. Director of Quality Assurance in the Bay Area, CA.
For more than 50 years, Cordis has pioneered less invasive treatments for cardiovascular disease. Hundreds of millions of people globally have some type of cardiovascular disease with only a small percentage actually ever being diagnosed. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis one of the world's leading developer and manufacturer of breakthrough products for interventional medicine. Given this significant business need and tremendous opportunity to help our customers around the world and the patients that they treat every day, we are searching for highly talented undergraduate students to join us on our journey to lead the fight against Cardiovascular Disease.
We are looking for leaders to bring health care solutions to our customers and communities in virtually every corner of the world…leaders to nurture and inspire others…leaders who are committed to making a difference…individuals with strong character and proven competencies needed to become tomorrow's leaders in a global environment. Our business principles are embodied in Our Credo, a respected, legendary value statement that has guided our Family of Companies.
Develops, implements, and coordinates product assurance programs to prevent or eliminate defects in new or existing products to ensure that all released products are safe, effective and of the highest quality and ensures compliance to all regulatory requirements by performing the following duties personally or through subordinate supervisors.
Provide Quality leadership, strategy and technical guidance. Responsible for developing business solutions for manufacturing, new product development, and process improvement. Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program. Conducts management meetings with department heads to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
Provide technical guidance and leadership to support field complaints and production problems. Brings those in need of corrective action to upper management's attention. Assures implementation of corrective action as required, and assures compliance to procedures and regulations by requesting and monitoring corrective actions as necessary. Responsible for ensuring personal and company compliance with all Federal, State, local and company. regulations, policies and procedures for Health, Safety and Environmental compliance
Ensure that a suitable and effective Quality System is established and maintained in harmony with the Franchise Quality System and in accordance with applicable standards and regulations, and report on the performance of the Quality System to Business Unit Management. Ensure that an effective organization is established and maintained to support and implement the overall Cordis Quality System. Serves as the Management Representative for the Cordis Franchise . Represents the company during compliance inspections by United States regulatory agencies, Notified Body and foreign governments for compliance inspections, as required.
May act in the capacity of designated official correspondent with the FDA in matters of enforcement actions and related inspections. Formal designee as the Management Representative of the Quality System for Cordis. Responsible for ensuring management reviews of the quality system are conducted. Maintains up-to-date knowledge of global medical device regulations and standards affecting Operating Group’s companies product development, manufacturing and distribution activities. Provides updates to company, franchise management and Johnson & Johnson corporate quality regarding compliance status and performance of the companies within the Operating group relating to quality. Plans and directs resources and activities of the quality and compliance functions.
Directs implementation of product recalls, market withdrawals and safety alerts in collaboration with Regulatory Affairs for international involvement.Manages subordinates at multiple sites and at the different companies within the Operating Group, in areas of quality and compliance and is responsible for the overall direction, coordination and evaluation of these sites/companies. Provides consultation to all functional management groups by providing compliance input for new projects, including but not limited to, product development, manufacturing and distribution. Directs implementation of new Quality & Compliance programs required by regulations or Johnson & Johnson directives.
Establishes and maintains Quality programs, procedures, and controls between core teams. Ensures that performance and quality of products conform to established company and regulatory standards. Manages all aspects of product sterilization from validation through product release. Advises staff to help meet established schedules or resolve technical or operational problems. Formulates and maintains quality objectives and coordinates objectives with pre-production and production procedures in cooperation with other manufacturing managers to maximize product reliability and minimize costs. Maintains an up to date knowledge in the techniques of quality and in the company products and process technologies.
Manages customer satisfaction process including applicable global MDR/vigilance reporting activities. Oversees compliance, inspections, quality engineering, quality systems, inspectors, document control, microbiology, customer satisfaction, and labeling and product release functions. Acts in the capacity of designated Official Correspondent with the Food and Drug Administration and State of California in matters of establishment registrations and related matters. Estimates and administers budget schedules and performance standards.
Active representative on the Cordis Management Board. Accountable for supporting the MD&D Quality Management Systems Working Group. The working group assures that the Quality Systems in MD&D converge toward the JJQS vision of one quality system. Responsible for providing Business Quality input to the development of the architecture of MD&D quality systems. Will assure that the Quality Systems goals of their Business are aligned with those of JJQS. Will collaborate with members of the Working Group to support agreed to initiatives of this team.
Qualifications
Bachelor’s degree in engineering and/or scientific discipline or equivalent plus minimum of 12 years experience as a Quality Professional in the Medical Device industry required. Master's degree in applicable field preferred.
Minimum of 5 years prior supervisory and a demonstrated ability to effectively train and mentor a diverse array of employees at all levels of the organization is required.
The ability to analyze and interpret the most complex documents and the ability to define problems, collect data, establish facts, and draw valid conclusions is required. The ability to respond effectively to the most sensitive inquiries or complaints. The ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Knowledge of mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis is required. Demonstrated ability to build and develop a strong management team that is accountable, delivers results, meets commitments is required. Demonstrated ability to build a strong management team across multiple site locations is required.
Must be able to travel extensively domestically and internationally.
Superior verbal and written communication skills and ability to effectively communicate with internal and external personnel at all levels of the organization. Ability to make solid decisions that will effectively support the business and company policies.
In-depth knowledge and practical application of quality and manufacturing systems and processes and relevant regulations, i.e. ISO 13485, FDA’s GMP and QSR requirements for medical devices is required. Superior regulatory, technical and business knowledge to develop operational strategies for continued quality assurance is required. The ability to develop long-term strategies and implement corresponding performance standards is required. Demonstrated analytical and problem solving skills.
Demonstrated working knowledge and experience in managing third party inspections and negotiating with 3rd parties on compliance issues is required. Excellent management skills required. Well-developed Influencing and negotiation skills required. Ability to effectively train and mentor a diverse array of employees at all levels of the organization. CQM or CQE certification from the American Society for Quality (ASQ) or equivalent is a plus. Skilled at preparing executive briefings and broad communications. Strong business and financial acumen. Highest ethical standards and integrity.
The ability to influence and negotiate at all levels of management and with business partners, both internal and external, is required.
This position is located in Freemont, CA and requires 30% travel national, may require occasional international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement