Software & Technology II – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Oct 17, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min 



Software and technology touches virtually every aspect of the global food supply chain. The positive impact on time- and temperature-sensitive perishables is especially profound, helping to support longer and more complex supply chains, omnichannel grocery, regulatory compliance and recall events, to name a few.


Amphenol FSI: Quality Manufacturing Engineer

Position requires candidates to be U.S. person as defined in ITAR, 22CFR 120.15 (U.S. Citizenship or Resident Alien Status)

Amphenol Fiber Systems International (AFSI) is a full service fiber optic company specializing in the fabrication of manufacture of fiber optic connectivity products and systems.  Our commitment to technical excellence makes us an industry leader in proficing sophisticated products and professional technical assistance in the fiber optic industry.  AFSI, located in Allen, Texas, has and will continue to base its strategy on technical and application support, quality assurance, product performance and value.

The Quality Manufacturing Engineer is responsible for understanding and interpreting all customer requirements to the Organization’s operations, and ensuring that the organization manufacturers product that meets or exceeds customers’ expectations. Position requires breadth of experience across multiple programs, products and customers to determine the right level of actions to improve / maintain the customer experience in all situations.

 Essential Functions:

  • Review customer drawings, specifications and contracts; interpret customer requirements and flow them down to the appropriate functions in the organization
  • Primarily responsible for understanding all customer requirements and communicating them during bid and contract reviews
  • Conduct FAI review and assessment
  • Conduct drawing reviews; audit Organization’s production drawings against customer drawings and requirements
  • Coordinate failure analysis; ensure true root cause identification and appropriate correct actions
  • Manage coordination of improvements; standardizing workmanship across the organization
  • Conduct internal quality audits in accordance with internal processes
  • Conduct customer quality audits to include design review
  • Work closely with Product Line Managers on new product introductions and ensuring customer expectations/requirements are met; assist in auditing Qualification Test Matrix against customer requirements
  • Manage documentation organization
  • Facilitate customer training
  • Some minimal travel may be required

Required Knowledge, Skills, and Abilities:

  • Proactive with desire to improve organization performance
  • Familiarity with software development, testing, introduction and upgrades
  • Ability to establish rapport with and elicit cooperation from people at all levels of an organization
  • Strong analytical and organizational skills
  • Strong oral and written communication skills, with the ability to influence & negotiate at all levels
  • Ability to make decisions and excel in situations characterized by uncertainty
  • Familiarity with ISO9000 desired
  • Strong project management skillset; detail oriented
  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Strong understanding of best practices in customer service

 Required Education and Experience:

  • Bachelor’s degree in Mechanical Engineering or related field
  • 2 -5 years’ experience in manufacturing quality engineering, process engineering or product engineering
  • Zero Defect Planning experience
  • Advanced Product Quality Planning (APQP) experience
  • 5 Why root cause analysis experience
  • S. person as defined in ITAR, 22CFR 120.15 (U.S. Citizenship or Resident Alien Status)


To apply for this position, please follow this link to complete the application process.

Lean 6-Sigma SIG – Monthly Meeting – 2018 September

Topic:  An Introduction to TRIZ, The Theory of Inventive Problem Solving

Ever been stuck on a problem with no idea how to attack it? Or, come up with a solution that was just too complicated to implement? At this month’s meeting com learn about TRIZ (теория решения изобретательских задач), the Theory of Inventive Problem Solving. TRIZ is a systematic approach to understanding your problem, finding a solution, and simplifying complex designs. How you ask? Because through TRIZ you will learn that someone somewhere has already solved your problem.

Speaker Bio

John Ellis is currently Sr. Manager – Continuous Improvement and Strategic Project Portfolio, HR and Legal for NEC Corporation of America. He is a PMI certified PMP (Project Management Professional), an ASQ Certified Six Sigma Black Belt and a Textron Certified DFSS Black Belt and Master Black Belt. Prior to entering the world of Six Sigma he created and then managed the IT Project Management Office at Bell Helicopter. He has a long and varied IT background including managing data networks, IT product and vendor management, developing application architecture and standards, and operating systems programming. He is a graduate of the University of Southern California with a BA in Mathematics and German. John enjoys classical music and Broadway shows, plays piano, and is interested in foreign languages having studied French, Chinese Mandarin and American Sign Language in addition to his degree in German.

For more details: Calendar Event

Pest Management’s Role in Food Safety and FSMA Compliance – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Complimentary Webinar on Sep 26, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT


Complimentary Webinar

Pest Management’s Role in Food Safety and FSMA Compliance


Pests are a major threat to the integrity of food products and a threat to any facility’s bottom line. With the Food Safety Modernization Act (FSMA) in full effect, preparation is more important than ever. FSMA mandates a proactive approach to food safety, and by extension pest management. It’s important to have an Integrated Pest Management program in place that is exhaustive and integrates seamlessly into the overarching food safety plan.

Join Orkin’s Chelle Hartzer and Savour Food Services International’s Gina Kramer, as they bring their knowledge and expertise to your facility with a free webinar to discuss preventive pest management controls that should be implemented to help ensure you and your staff are operating the safest food facility possible.

Learning Objectives:

During this free, hour-long webinar you’ll learn about:

  • Key componentsof FSMA as they relate to pest control
  • Common factors that affect preventive controls
  • Establishing preventive controls
  • How to measure success with an IPM Plan

Who Should Attend:

During this free, hour-long webinar you’ll learn about:

  • Food Processing Professionals
  • Quality Assurance Directors


Chelle Hartzer, BCE
Chelle Hartzer, BCE Technical Services Manager Orkin
Gina R. Nicholson-Kramer, RS REHS
Gina R. Nicholson-Kramer, RS REHS Executive Director, Savour Food Safety International


Understanding BRC Global Standard for Food Issue 8 – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Sep 06, 2018 | Duration: 60 Min By: John Kukoly, Jennifer Lott


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This Webinar presented by SGS explores the newest version of BRC Global Standard for Food – Issue 8 and the changes included in the revision.

The objective of this webinar (45-minute presentation / 15-minute Q&A) is to bring awareness to food industry companies affected by the changes in the updates and revisions for the BRC Global Standard for food.


  • Overview of BRC Global Standard for Food Issue 8
  • Key Changes to Issue 8
    • Food Safety Culture
    • Environmental Monitoring
    • Product Security and Food Defense
    • High Risk, High Care and Ambient High Care Production Risk Zones
    • Pet Food
  • Additional Modules – FSMA, Gluten Free, Food Safety & Quality Culture etc.
  • Issue 8 Timeline
  • How to Prepare and Get Ready
  • Q&A


The focus of the newest version of BRC Global standard for food has been encouraging development of product safety culture. There has been an expansion of the requirements for environmental monitoring to reflect the increasing importance of this technique. Sites have been encouraged to further develop systems for security and food defense.

Issue 8 has added clarity to the requirements for high risk, high care and ambient high care production risk zones. Thus, providing greater clarity for sites manufacturing pet food and to ensure global applicability and GFSI benchmarking.

There will be a continued emphasis on management commitment. Hazard Analysis and Critical Control Point (HACCP) – based food safety program and supporting quality management system are recommended. And the implementation of good manufacturing practices within the production areas will add emphasis on areas which have traditionally resulted in recalls and withdrawals (e.g. label and packing management).


John Kukoly

John Kukoly is the Americas Director for the BRC Global Standards team, responsible for the BRC programs throughout the America’s. The BRC Global Standard for Food Safety and the BRC Global Standards are regarded around the world as the leading food safety and quality certification program. John brings a wealth of experience and expertise to BRC and the GFSI technical working groups, with more than 20 years management experience in the food production and certification industry. He has had previous roles in quality, engineering and auditing.

Jennifer Lott

At SGS North America serves as a technical resource for GFSI approved auditing schemes, including FSSC 22000 food manufacturing, BRC Storage & Distribution, Packaging, and Consumer Products, RSPO, GMP/HACCP and is an accredited multi-sector Food Safety Program Lead Auditor and Trainer. Jennifer has over 25 years experience in quality assurance management, food safety management system development consulting, packaging, laboratory management, training and auditing. Jennifer holds a Bachelor of Science degree in chemistry from the College of Mount St. Joseph.

Target Audience
The webinar is aimed at Food Safety Quality Managers and Supervisors, Internal Auditors, Consultants, and those interested in learning more about BRC Global Standard for Food Safety Issue 8

Language: English
Cost: No Charge

If you can’t make a live session, please register in order to receive a complimentary recording after the live event.


How FDA Evaluates Your Quality Management System – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Jul 27, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT


Unable to attend Live!!
Subscribe for Recorded

Short Abstract:

QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.

Areas Covered in the Webinar:

  • Introduction to FDA Regulations
  • Overview of Quality System Regulations (“QSR”)
  • How FDA Evaluates Your Quality Management System (“QMS”)
  • Most Inclusive Requirement: Document Control
  • Most Critical FDA Non-conformances
  • Most Common FDA Non-conformances

For More Information Kindly Click here or Copy and Paste Below Link


FDA Software Validation and Verification, Computer System Validation: Step-by-Step – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Aug 08, 2018 | Available All Day | Duration: 60 Min By: Carolyn Troiano


The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best practices for meeting these requirements isn’t always clear. Your software may be compliant, but you may not be. This webinar provides you answers to the top most Six common software validation and documentation questions asked by the others in FDA regulated industries and express the best practices for meeting the instruction.

The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated. While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they have to need that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a best result of assurance that a specific process will always generate the expected result or output of the given input.

Documentation is required for Regulatory Validation:

  • Software Validation Protocol (Validation Plan)
  • System /Software Requirements Specification
  • Network Diagram
  • Risk Analysis
  • 21 CFR Part 11 Compliance Analysis
  • Verification Protocol (Test Plan)

Session Highlights:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • User Requirements Specification (URS) to include high-level needs in language familiar to the user
  • Operational Qualification (OQ)
  • System Acceptance by the user or owner of the system
  • ….. and more



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