Johnson & Johnson companies are equal opportunity employers.
QUALITY ENGINEERING MANAGER-0165130927
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Engineering Manager 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 Plant Quality Engineering Manager will provide Quality engineering support to capital equipment and consumable products manufacturing. She/ He will establish and manage all Quality Assurance systems required to support Operations at the ASP Irvine facility. She/ He will provide quality engineering leadership during investigation of issues pertaining to products and processes by applying effective QE tools and will support the design transfer, process validation, and continuous improvement activities in a cross-functional environment. She/ He will take a lead role in mentoring and coaching individuals and teams while resolving problems and implementing best practices. Take a role as an SME in various QE related processes and methodologies.
Provide quality engineering leadership on projects while staying in compliance with FDA, ISO, EU and CMDR regulations and ASP Quality System requirements. Provide technical guidance to project teams in various QE areas such as DMAIC, Process Capability, Trouble Shooting, Root Cause Analysis, Process Validation, FMEA, FTA hazard analysis, Test Method Development, Sampling Strategy, and other Statistical Tools. Lead product and process related CAPAs for eliminating existing issues and improving process efficiency. Track and trend quality data for nonconformance’s, CAPA and Change Control. Lead teams in conducting investigations related to nonconformance’s and/or customer complaints. Identify opportunities for process improvements.
Implement improvements to quality system processes, provide audit support. Execute functions needed to support site change control and documentation management. Interaction with customers and suppliers. Perform supplier audits as needed. Oversee day to day Quality Operations support, Quality Engineering and ensuring Process Validation and Verification Compliance. Will be responsible for the escalation and investigation of Product Quality Issues, coordination of Plant Management Reviews and will participate and collaborate with Supply Chain, R&D Engineering, Operations Engineering and Manufacturing leaders to identify potential areas of process variability, address root causes and implement improvement.
Qualifications
This position requires a Bachelor of Science in Engineering, Science, Medical Technology, or Business and 7+ years of related experience or MS/MBA degree in Engineering, Science, Medical Technology or Business and 5+ years of related experience or a PhD in Science, Medical Technology or Business and 3+ years of related experience.
An ASQ certification as a QE or equivalent is preferred.
A Six Sigma Green or Black Belt certification is preferred.
Experience with Lean techniques is required.
Experience computing statistics and statistical process controls is required.
Experience with CAPA’s is required.
Experience with Risk Management, process validation, Quality Systems Requirements, problem solving/root cause investigation are required.
This position is located in Irvine and required 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
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
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
QUALITY ENGINEERING MANAGER-0165130927
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Engineering Manager 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 Plant Quality Engineering Manager will provide Quality engineering support to capital equipment and consumable products manufacturing. She/ He will establish and manage all Quality Assurance systems required to support Operations at the ASP Irvine facility. She/ He will provide quality engineering leadership during investigation of issues pertaining to products and processes by applying effective QE tools and will support the design transfer, process validation, and continuous improvement activities in a cross-functional environment. She/ He will take a lead role in mentoring and coaching individuals and teams while resolving problems and implementing best practices. Take a role as an SME in various QE related processes and methodologies.
Provide quality engineering leadership on projects while staying in compliance with FDA, ISO, EU and CMDR regulations and ASP Quality System requirements. Provide technical guidance to project teams in various QE areas such as DMAIC, Process Capability, Trouble Shooting, Root Cause Analysis, Process Validation, FMEA, FTA hazard analysis, Test Method Development, Sampling Strategy, and other Statistical Tools. Lead product and process related CAPAs for eliminating existing issues and improving process efficiency. Track and trend quality data for nonconformance’s, CAPA and Change Control. Lead teams in conducting investigations related to nonconformance’s and/or customer complaints. Identify opportunities for process improvements.
Implement improvements to quality system processes, provide audit support. Execute functions needed to support site change control and documentation management. Interaction with customers and suppliers. Perform supplier audits as needed. Oversee day to day Quality Operations support, Quality Engineering and ensuring Process Validation and Verification Compliance. Will be responsible for the escalation and investigation of Product Quality Issues, coordination of Plant Management Reviews and will participate and collaborate with Supply Chain, R&D Engineering, Operations Engineering and Manufacturing leaders to identify potential areas of process variability, address root causes and implement improvement.
Qualifications
This position requires a Bachelor of Science in Engineering, Science, Medical Technology, or Business and 7+ years of related experience or MS/MBA degree in Engineering, Science, Medical Technology or Business and 5+ years of related experience or a PhD in Science, Medical Technology or Business and 3+ years of related experience.
An ASQ certification as a QE or equivalent is preferred.
A Six Sigma Green or Black Belt certification is preferred.
Experience with Lean techniques is required.
Experience computing statistics and statistical process controls is required.
Experience with CAPA’s is required.
Experience with Risk Management, process validation, Quality Systems Requirements, problem solving/root cause investigation are required.
This position is located in Irvine and required 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
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
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
