Johnson & Johnson companies are equal opportunity employers.
STAFF NPI QE-1498140206
Description
Advanced Sterilization Products, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer- New Product Development, located in Irvine, CA.
Advanced Sterilization Products (ASP), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection, Area Decontamination 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.
The Staff NPI Quality Engineer will be responsible for:
Providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends.
Provide constructive technical challenge to the design and development of a product or process to drive better product or process performance and project outcomes.
Develop the Reliability Requirement for products and provides demonstrate leadership in driving product reliability requirements and objectives full implementation.
Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
Lead project teams to utilize risk management and process excellence tools and effectively drives reasonable and appropriate risk controls.
Lead complex investigations, coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations.
Provide Advanced Statistical Analysis support and utilize various Statistical Analysis techniques and tools. Conduct or support failure and complaint investigations.
Initiate and supports continuous process improvements within area of responsibility, and conducts supplier quality system and product audits as needed.
Support, perform, or oversee Internal and External Audits and CAPAs; be accountable for preparing and tracking Audit Finding Reports (AFRs) in response to observations from Internal and External Inspections / Audits to ensure compliance with Quality Management System elements.
Serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product).
Provide backroom support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
Qualifications
This position will require a minimum
B.S. in Mechanical or Electrical Engineering or equivalent with 10 or more years of related experience; or Master's degree in Mechanical, Electrical Engineering discipline plus 7 or more years of related experience and/or training; or Ph.D. in an Mechanical, Electrical Engineering discipline and 5 or more years of related experience.
Minimum of 7 years Quality Systems or Quality Assurance work experience and minimum of 5 years Quality Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820, ISO 13485 and ISO 9001. Ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise is required.
Strong understanding of appropriate Risk Management regulations and guidance standards, such as, ISO 14971 and FDA Guidance and thorough understanding in the application of risk management tools, such as, Risk Analysis, FMEA and FTA
Provide leadership that ensures Quality program initiatives are aligned with the business’ needs.
Strong Quality Engineering skills with working knowledge of product design verification, as well as product and process validation activities
Excellent both written and verbal communication skill and capable of working independently and in a team setting. Ability to work and communicate in a cross-cultural environment.
Lead a high performance team and drive performance results and work with core teams and development partners to ensure robust design quality practices are embedded and applied
Lead continuous improvement of the new product development processes and procedures and ability to integrate reliability techniques as a part of product development or design changes
Leadership ability in using problem solving techniques including root cause analysis and cause and effect analysis is required
Leadership ability in developing achievable high-quality product reliability requirements for products in partnership with various departments, such as, R&D, Operation, Service etc and managing the implementation and execution of these reliability goals.
Serves as the technical subject matter and expert and communicates to auditors and investigators
Ability to effectively utilize knowledge of Qualitative Reliability Techniques (such as dFMEA, pFMEA, DFx); Environmental Qualitative Reliability Tests (HALT and HASS) and Reliability Prediction and Ongoing Reliability Test (ORT) are preferred.
A working knowledge Statistical Analysis Software tools, such as, MiniTab, Statgraphics, QI Macros SPC Software, etc.; demonstrated proficiency in Six Sigma Methodology is required.
Use of investigative tools (Cause and Effect Diagrams, Process Optimization, Design of Experiments, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.).
Preferred experiences are: Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.) or Flawless Project Execution Certificate.
This position may require approximately 10-15% national and international travel and will be based in Irvine California.
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: Ethicon Inc. (6045)
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 NPI QE-1498140206
Description
Advanced Sterilization Products, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer- New Product Development, located in Irvine, CA.
Advanced Sterilization Products (ASP), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection, Area Decontamination 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.
The Staff NPI Quality Engineer will be responsible for:
Providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends.
Provide constructive technical challenge to the design and development of a product or process to drive better product or process performance and project outcomes.
Develop the Reliability Requirement for products and provides demonstrate leadership in driving product reliability requirements and objectives full implementation.
Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
Lead project teams to utilize risk management and process excellence tools and effectively drives reasonable and appropriate risk controls.
Lead complex investigations, coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations.
Provide Advanced Statistical Analysis support and utilize various Statistical Analysis techniques and tools. Conduct or support failure and complaint investigations.
Initiate and supports continuous process improvements within area of responsibility, and conducts supplier quality system and product audits as needed.
Support, perform, or oversee Internal and External Audits and CAPAs; be accountable for preparing and tracking Audit Finding Reports (AFRs) in response to observations from Internal and External Inspections / Audits to ensure compliance with Quality Management System elements.
Serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product).
Provide backroom support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
Qualifications
This position will require a minimum
B.S. in Mechanical or Electrical Engineering or equivalent with 10 or more years of related experience; or Master's degree in Mechanical, Electrical Engineering discipline plus 7 or more years of related experience and/or training; or Ph.D. in an Mechanical, Electrical Engineering discipline and 5 or more years of related experience.
Minimum of 7 years Quality Systems or Quality Assurance work experience and minimum of 5 years Quality Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820, ISO 13485 and ISO 9001. Ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise is required.
Strong understanding of appropriate Risk Management regulations and guidance standards, such as, ISO 14971 and FDA Guidance and thorough understanding in the application of risk management tools, such as, Risk Analysis, FMEA and FTA
Provide leadership that ensures Quality program initiatives are aligned with the business’ needs.
Strong Quality Engineering skills with working knowledge of product design verification, as well as product and process validation activities
Excellent both written and verbal communication skill and capable of working independently and in a team setting. Ability to work and communicate in a cross-cultural environment.
Lead a high performance team and drive performance results and work with core teams and development partners to ensure robust design quality practices are embedded and applied
Lead continuous improvement of the new product development processes and procedures and ability to integrate reliability techniques as a part of product development or design changes
Leadership ability in using problem solving techniques including root cause analysis and cause and effect analysis is required
Leadership ability in developing achievable high-quality product reliability requirements for products in partnership with various departments, such as, R&D, Operation, Service etc and managing the implementation and execution of these reliability goals.
Serves as the technical subject matter and expert and communicates to auditors and investigators
Ability to effectively utilize knowledge of Qualitative Reliability Techniques (such as dFMEA, pFMEA, DFx); Environmental Qualitative Reliability Tests (HALT and HASS) and Reliability Prediction and Ongoing Reliability Test (ORT) are preferred.
A working knowledge Statistical Analysis Software tools, such as, MiniTab, Statgraphics, QI Macros SPC Software, etc.; demonstrated proficiency in Six Sigma Methodology is required.
Use of investigative tools (Cause and Effect Diagrams, Process Optimization, Design of Experiments, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.).
Preferred experiences are: Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.) or Flawless Project Execution Certificate.
This position may require approximately 10-15% national and international travel and will be based in Irvine California.
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: Ethicon Inc. (6045)
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