Johnson & Johnson companies are equal opportunity employers.
Staff Specialist,Quality Systems-2024140401
Description
LifeScan, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Staff Specialist, Quality Systems, for its office in Wayne, PA.
LifeScan is the leading manufacturer of blood glucose monitoring systems in the U.S. More than 5 million people depend on the company’s OneTouch® Brand Products for simple testing and accurate results to help them manage their diabetes. In addition, OneTouch® products are recommended by more Healthcare Professionals than any other brand. Consisting of a portable electronic meter and disposable reagent test strips, our systems provide results in just 5 seconds and include tools to help transform results into actionable health care decisions. To learn more visit www.OneTouch.com.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Staff Specialist Quality Systems is responsible for the Global Management and Implementation of Quality Systems process and procedures for the WW Quality System & Compliance group to include, but not limited to: CAPA / NC / D&DC / Training / Management Review / External Standards, ensuring focus on meeting Regulatory, compliance and customer requirements. Deputise for WW Manager as directed.
The Staff Specialist, Quality Systems is responsible for system management to include implementation, upgrades and enhancements. S/he ensures implementation of DCF and MD&D alignment, prioritization of system changes and rollout DCF/MD&D Alignment Processes, oversight for consistency of Global Quality System Processes, acts as an SME for Quality System processes to key stakeholders and for audits, and executes internal audit observations/ NC / CAPA as required. This individual also is responsible for the development of training materials (E Learning, other), conducts concept training on Quality Systems, and advises on qualification creation, management, and rollout. S/he develops Quality System metrics and analyze data, provide conclusions, and recommendations and resulting action plans, identify & implement appropriate metrics to report and at which level, present metrics to review forums as required, and conduct Internal Audits, support 3rd party / regulatory inspections.
Qualifications
A Bachelors Degree is required. 5+ years of experience in Compliance, Quality Systems or Quality Assurance within a Medical Devices and Diagnostics and other regulated, healthcare industries is required. 5+ years preferred, international standards & regulations is preferred. Proficiency in using software systems, understanding of functionality and ability to liaise with IT on system enhancements and prioritization and suggest improvements including the ability to translate needs into system requirements is required. Ability to analyze and make decisions based on data gathered is required. Project Management experience including leading global, cross functional projects is required. 2+ years knowledge and experience in quality system is required. Ability to effectively communicate (orally or via written communication) changes, updates, process improvements to the business partners or members of the organization is required. Experience implementing and deploying new processes and systems is required. Experience managing projects using process excellence tools and methodologies is required. ASQ certification preferred. Knowledge of FDA Quality System Regulations and ISO 13485 Standard is strongly preferred. Knowledge of supply chain and research and development operations as it relates to the medical device industry is preferred. Experience with multiple, global quality systems implementations such as Audits, CAPA, Non-Conformance, Change Control, Design Controls and Document and Data Control, Training and Records Management to include the use of process excellent methodologies for new initiatives and process/system improvements is desired. Process Excellence certification (i.e., GB, BB, MBB); ASQ certification or equivalent (i.e. CQA, CQE); ISO Auditor; Project Management skills; Change Management skills are preferred.. People manangement experience is preferred. This position is located in Wayne, PA. There is up to 15%domestic and international travel for this position.
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
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Wayne
Organization: Lifescan Inc. (6097)
Job Function: Quality Systems
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
Staff Specialist,Quality Systems-2024140401
Description
LifeScan, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Staff Specialist, Quality Systems, for its office in Wayne, PA.
LifeScan is the leading manufacturer of blood glucose monitoring systems in the U.S. More than 5 million people depend on the company’s OneTouch® Brand Products for simple testing and accurate results to help them manage their diabetes. In addition, OneTouch® products are recommended by more Healthcare Professionals than any other brand. Consisting of a portable electronic meter and disposable reagent test strips, our systems provide results in just 5 seconds and include tools to help transform results into actionable health care decisions. To learn more visit www.OneTouch.com.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Staff Specialist Quality Systems is responsible for the Global Management and Implementation of Quality Systems process and procedures for the WW Quality System & Compliance group to include, but not limited to: CAPA / NC / D&DC / Training / Management Review / External Standards, ensuring focus on meeting Regulatory, compliance and customer requirements. Deputise for WW Manager as directed.
The Staff Specialist, Quality Systems is responsible for system management to include implementation, upgrades and enhancements. S/he ensures implementation of DCF and MD&D alignment, prioritization of system changes and rollout DCF/MD&D Alignment Processes, oversight for consistency of Global Quality System Processes, acts as an SME for Quality System processes to key stakeholders and for audits, and executes internal audit observations/ NC / CAPA as required. This individual also is responsible for the development of training materials (E Learning, other), conducts concept training on Quality Systems, and advises on qualification creation, management, and rollout. S/he develops Quality System metrics and analyze data, provide conclusions, and recommendations and resulting action plans, identify & implement appropriate metrics to report and at which level, present metrics to review forums as required, and conduct Internal Audits, support 3rd party / regulatory inspections.
Qualifications
A Bachelors Degree is required. 5+ years of experience in Compliance, Quality Systems or Quality Assurance within a Medical Devices and Diagnostics and other regulated, healthcare industries is required. 5+ years preferred, international standards & regulations is preferred. Proficiency in using software systems, understanding of functionality and ability to liaise with IT on system enhancements and prioritization and suggest improvements including the ability to translate needs into system requirements is required. Ability to analyze and make decisions based on data gathered is required. Project Management experience including leading global, cross functional projects is required. 2+ years knowledge and experience in quality system is required. Ability to effectively communicate (orally or via written communication) changes, updates, process improvements to the business partners or members of the organization is required. Experience implementing and deploying new processes and systems is required. Experience managing projects using process excellence tools and methodologies is required. ASQ certification preferred. Knowledge of FDA Quality System Regulations and ISO 13485 Standard is strongly preferred. Knowledge of supply chain and research and development operations as it relates to the medical device industry is preferred. Experience with multiple, global quality systems implementations such as Audits, CAPA, Non-Conformance, Change Control, Design Controls and Document and Data Control, Training and Records Management to include the use of process excellent methodologies for new initiatives and process/system improvements is desired. Process Excellence certification (i.e., GB, BB, MBB); ASQ certification or equivalent (i.e. CQA, CQE); ISO Auditor; Project Management skills; Change Management skills are preferred.. People manangement experience is preferred. This position is located in Wayne, PA. There is up to 15%domestic and international travel for this position.
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
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Wayne
Organization: Lifescan Inc. (6097)
Job Function: Quality Systems
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