Johnson & Johnson companies are equal opportunity employers.
STAFF QUALITY SYSTEMS ENGINEER-9094140120
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Systems Engineer, located in Irvine, CA.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The Staff Quality Systems Engineer will support capital equipment, consumables, and other products manufacturing. The individual will be proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with statistical methods, sampling, design of experiments, process capability analysis, FMEA, and FTA hazard analysis. The Staff Quality Systems Engineer will lead the nonconformance process including initiating, evaluating, dispositioning NCRs and managing the process for Rapid Response Team toward dispositioning products in a timely manner. Provide guidance for material transactions in SAP that relate to incoming inspection, batch release, non conformance, etc. Manage and lead the process for stop shipment and first article inspection and related transactions. Provide guidance to the team for creating monthly supply chain metric and insight how to improve the metrics.
The purpose of this role is to collaborate with business partners to ensure compliance to all regulatory standard requirements. Specific areas of focus will be:
Monitor sources of quality data (NCs, Internal Audits and other QS metrics as applicable to ensure appropriate review and escalation through risk management system. Monitor support and maintain the NCR program by coordinating MRB’s ensuring NCR closure, and monitoring investigation and correction implementation. Monitor and support stop shipments, and recall activities as required. Assist in the coordination and execution of audits of internal and external processes to ensure compliance to applicable procedures and requirements. Responsible for the coordination and reporting of Quality Operations metrics for monthly management reviews. Serve as the Quality Systems SME for the Quality Operations department and serve as the liaison between Quality Operations Supply Chain and the Quality systems department
Responsible for utilizing effective and efficient Quality techniques such as risk analysis, test method development, design of experiments, statistical data analysis, measurement system analysis, and development of sampling plans throughout the product lifecycle. Conduct and participate in troubleshooting investigation efforts utilizing process excellence methodologies to solve problems and develop optimal products and processes and Identify trends and reoccurring issues and suggesting solutions. Lead and support the develop comprehensive quality strategies for support of manufacturing, process V&V, and risk management. Partner with Operations, R&D, QRC and other departments to ensure products are efficiently and effectively transferred and integrated into steady-state manufacturing. Handle multiple competing priorities and leads large complex projects with the particular emphasis on timelines, and supporting project documentation and delivers results. Demonstrates Leadership abilities and provides coaching and mentoring for engineers, analysts, and partners on the quality systems process, interpretation and implementation and execution of QSR requirements. As required Support the day to day Quality operations activities including but not limited to: Review of procedures and controls to ensure that performance and quality of product conforms to the established processes and procedures. Assisting in the troubleshooting and root cause investigations of non-conforming product. Lead and or participate in risk analysis, process FMEAs, quality strategies, and the design and development of verification and validation protocols and reports
Will observe & comply all Company’s Environmental, Safety, and Industrial Hygiene policies and regulations. Follows all guidelines established in the organization for the implementation and continuous improvement of the ISO system. Furthermore this role ensures all personnel under their facilitation complies with all Safety and Environmental policies and procedures (Plant-wide and applicable to work area). Performs other duties as assigned by management.
Qualifications
The requirements for this role are as follows:
Bachelors’ Degree, Engineering, Science, Medical Technology, Microbiology preferred. ASQ certified QE, QA, or equivalent, Six Sigma Green or Black Belts highly desirable.
Minimum of 5 years of experience in design/manufacturing environment with Bachelors degree, 3-5 years of experience in design/manufacturing environment with MS/MBA degree, or 2+ years of experience working in Medical Device or Pharmaceutical environment.
Experience with non-conformances. FMEAs, and CAPAs is required. Working knowledge of first article inspection, in-coming/ in-process inspections, lot release testing and sampling plans required. Experience in a FDA regulated environment preferred. Experience with Medical Devices highly desired. Prior experience with FDA audits would be a plus. Experience working with cross functional teams such as Engineering, Operations, Supply Chain, Suppliers, New Product Development etc, is desired. Demonstrated working knowledge of QSRs 21 CFR 820 , ISO 13485, specifically in the areas of quality control, process verification and validation, quality systems: Risk Management, Corrective and Preventative Actions, Internal Audit and regulatory requirements. Experience with reading and interpreting mechanical drawings preferred. Ability to lead and/ or mentor others highly desired. Any quality related certifications or trainings would be a preference. Must be able to work independently with general direction, supervise less experienced engineers and analyst, partner with appropriate departments, and communicate effectively with all levels in the organization. Six Sigma GB or BB certification desirable. Microsoft applications, ERP system knowledge such as JDE, SAP etc, statistical package such as Minitab, etc.
This position is located In Irvine, CA and requires negligible 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-Irvine
Organization: Advanced Sterilization Products (ASP)
Job Function: Quality (Eng)
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 QUALITY SYSTEMS ENGINEER-9094140120
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Systems Engineer, located in Irvine, CA.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The Staff Quality Systems Engineer will support capital equipment, consumables, and other products manufacturing. The individual will be proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with statistical methods, sampling, design of experiments, process capability analysis, FMEA, and FTA hazard analysis. The Staff Quality Systems Engineer will lead the nonconformance process including initiating, evaluating, dispositioning NCRs and managing the process for Rapid Response Team toward dispositioning products in a timely manner. Provide guidance for material transactions in SAP that relate to incoming inspection, batch release, non conformance, etc. Manage and lead the process for stop shipment and first article inspection and related transactions. Provide guidance to the team for creating monthly supply chain metric and insight how to improve the metrics.
The purpose of this role is to collaborate with business partners to ensure compliance to all regulatory standard requirements. Specific areas of focus will be:
Monitor sources of quality data (NCs, Internal Audits and other QS metrics as applicable to ensure appropriate review and escalation through risk management system. Monitor support and maintain the NCR program by coordinating MRB’s ensuring NCR closure, and monitoring investigation and correction implementation. Monitor and support stop shipments, and recall activities as required. Assist in the coordination and execution of audits of internal and external processes to ensure compliance to applicable procedures and requirements. Responsible for the coordination and reporting of Quality Operations metrics for monthly management reviews. Serve as the Quality Systems SME for the Quality Operations department and serve as the liaison between Quality Operations Supply Chain and the Quality systems department
Responsible for utilizing effective and efficient Quality techniques such as risk analysis, test method development, design of experiments, statistical data analysis, measurement system analysis, and development of sampling plans throughout the product lifecycle. Conduct and participate in troubleshooting investigation efforts utilizing process excellence methodologies to solve problems and develop optimal products and processes and Identify trends and reoccurring issues and suggesting solutions. Lead and support the develop comprehensive quality strategies for support of manufacturing, process V&V, and risk management. Partner with Operations, R&D, QRC and other departments to ensure products are efficiently and effectively transferred and integrated into steady-state manufacturing. Handle multiple competing priorities and leads large complex projects with the particular emphasis on timelines, and supporting project documentation and delivers results. Demonstrates Leadership abilities and provides coaching and mentoring for engineers, analysts, and partners on the quality systems process, interpretation and implementation and execution of QSR requirements. As required Support the day to day Quality operations activities including but not limited to: Review of procedures and controls to ensure that performance and quality of product conforms to the established processes and procedures. Assisting in the troubleshooting and root cause investigations of non-conforming product. Lead and or participate in risk analysis, process FMEAs, quality strategies, and the design and development of verification and validation protocols and reports
Will observe & comply all Company’s Environmental, Safety, and Industrial Hygiene policies and regulations. Follows all guidelines established in the organization for the implementation and continuous improvement of the ISO system. Furthermore this role ensures all personnel under their facilitation complies with all Safety and Environmental policies and procedures (Plant-wide and applicable to work area). Performs other duties as assigned by management.
Qualifications
The requirements for this role are as follows:
Bachelors’ Degree, Engineering, Science, Medical Technology, Microbiology preferred. ASQ certified QE, QA, or equivalent, Six Sigma Green or Black Belts highly desirable.
Minimum of 5 years of experience in design/manufacturing environment with Bachelors degree, 3-5 years of experience in design/manufacturing environment with MS/MBA degree, or 2+ years of experience working in Medical Device or Pharmaceutical environment.
Experience with non-conformances. FMEAs, and CAPAs is required. Working knowledge of first article inspection, in-coming/ in-process inspections, lot release testing and sampling plans required. Experience in a FDA regulated environment preferred. Experience with Medical Devices highly desired. Prior experience with FDA audits would be a plus. Experience working with cross functional teams such as Engineering, Operations, Supply Chain, Suppliers, New Product Development etc, is desired. Demonstrated working knowledge of QSRs 21 CFR 820 , ISO 13485, specifically in the areas of quality control, process verification and validation, quality systems: Risk Management, Corrective and Preventative Actions, Internal Audit and regulatory requirements. Experience with reading and interpreting mechanical drawings preferred. Ability to lead and/ or mentor others highly desired. Any quality related certifications or trainings would be a preference. Must be able to work independently with general direction, supervise less experienced engineers and analyst, partner with appropriate departments, and communicate effectively with all levels in the organization. Six Sigma GB or BB certification desirable. Microsoft applications, ERP system knowledge such as JDE, SAP etc, statistical package such as Minitab, etc.
This position is located In Irvine, CA and requires negligible 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-Irvine
Organization: Advanced Sterilization Products (ASP)
Job Function: Quality (Eng)
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