1. What is a QA Engineer at Ormco?

As a QA Engineer at Ormco—specifically operating within the Global Manufacturing Engineering (GME) team as an Automation and Controls expert—you are at the forefront of modernizing and safeguarding the production of industry-leading orthodontic products. Ormco has spent over 60 years creating more than 20 million smiles globally, and this role is critical to sustaining that legacy through the Spark Clear Aligner System and other advanced dental solutions.

In this position, you do not just test software; you visualize and create the digital factory of the future. You are responsible for the quality, validation, and continuous improvement of complex, in-line automated manufacturing processes. This means pushing the limits of custom hardware and software automation while maintaining strict adherence to FDA regulations and ISO 13485 standards. Your work directly impacts mass customization at a global scale, ensuring that every product meets rigorous medical device tolerances.

Expect a highly dynamic, cross-functional environment. You will bridge the gap between mechanical design, software development, and daily factory operations. Whether you are programming PLCs and industrial vision systems, validating new manufacturing equipment, or leading root cause analyses to reduce machine downtime, your technical judgment will directly influence both product quality and the financial efficiency of Ormco.

2. Common Interview Questions

The questions below represent the types of technical, behavioral, and situational inquiries you will face. They are designed to test not only your baseline knowledge but how you apply it in a high-stakes manufacturing environment.

Automation & Manufacturing Processes

These questions test your hands-on experience with the specific hardware and software used on the factory floor.

• Walk me through your process for programming a PLC for a new piece of manufacturing equipment.
• How do you approach integrating an industrial vision system like Cognex into an existing production line?
• Tell me about a time you used SolidWorks to interpret a complex assembly and how it influenced your control system design.
• Describe your experience with industrial robotics. What specific platforms have you used, and what were their primary applications?
• How do you balance the need for high-speed mass customization with the limitations of custom hardware?

Quality & Regulatory Validation

These questions evaluate your commitment to medical device standards and your methodical approach to validation.

• Explain the steps you take to perform an equipment validation (IQ/OQ/PQ) to internal and FDA procedures.
• How do you ensure that a newly implemented automated process complies with ISO 13485?
• Tell me about a time you discovered a compliance risk during a process failure mode effects analysis (PFMEA). What did you do?
• Describe your experience maintaining regulatory and compliance documentation repositories.

Problem Solving & Root Cause Analysis

Interviewers want to see your analytical mindset when things break down on the production line.

• Describe a situation where a critical machine was experiencing frequent downtime. How did you identify the root cause?
• Tell me about a time you had to implement a temporary countermeasure to keep production running while developing a permanent solution.
• How do you use operational and financial reports to discern trends and justify equipment modifications?
• Give an example of how you worked with a maintenance department to redefine equipment maintenance requirements and reduce downtime.

Behavioral & Leadership

These questions focus on your ability to mentor, manage vendors, and drive projects to completion.

• Tell me about a time you had to lead and mentor a team of contractors who were underperforming.
• Describe a challenging interaction with an outside vendor regarding equipment specifications. How did you resolve the issue?
• How do you prioritize tasks and exercise judgment in a high-paced, real-time manufacturing environment?
• Explain how you go about training production teams on new automated processes and standard work documents.
• Tell me about a time you had to present a capital appropriation request or budget forecast to management.

3. Getting Ready for Your Interviews

Preparing for a manufacturing and automation-focused quality role requires a strategic blend of technical review and behavioral readiness. Your interviewers will look for candidates who understand both the theoretical principles of engineering and the practical realities of a high-volume, regulated production floor.

Here are the key evaluation criteria you should focus on:

Technical & Automation Proficiency You must demonstrate hands-on expertise with the hardware and software that drive modern manufacturing. Interviewers will evaluate your ability to program and troubleshoot PLCs, HMI/SCADA systems, industrial robotics, and vision systems (such as Cognex or Keyence), as well as your familiarity with object-oriented programming (.NET or C++) and 3D CAD software like SolidWorks.

Quality Systems & Regulatory Compliance Because Ormco produces medical devices, quality is non-negotiable. You will be assessed on your deep understanding of FDA regulations, ISO 13485, and your ability to execute rigorous equipment and process validations (IQ/OQ/PQ) to ensure robust, low-risk machine design.

Problem-Solving & Root Cause Analysis Manufacturing lines experience unexpected downtime and quality deviations. Interviewers want to see your structured approach to troubleshooting. You can demonstrate strength here by walking through past experiences where you identified a root cause, implemented a corrective action, and documented cost savings or uptime improvements.

Cross-Functional Leadership & Collaboration This is a hands-on leadership role. You will be evaluated on your ability to mentor teams of engineers and contractors, collaborate with project managers, and manage outside vendors. Strong candidates will show they can translate complex technical issues into clear, actionable plans for both technical and non-technical stakeholders.

4. Interview Process Overview

The interview process for the QA Engineer and Automation Controls roles at Ormco is thorough and designed to test both your theoretical knowledge and your practical floor experience. You can expect a process that moves deliberately, prioritizing candidates who show a strong alignment with Envista’s continuous improvement and LEAN manufacturing culture.

Typically, the process begins with a recruiter screen focused on your background, salary expectations, and basic qualifications (such as your experience with FDA environments and specific automation tools). This is followed by a technical phone or video screen with a hiring manager. During this stage, expect to discuss your resume in detail, particularly your past projects involving machine design, PLC programming, and process validation. They want to ensure your hands-on experience matches the scale of Ormco's operations.

The final stage is a comprehensive onsite or virtual loop consisting of several cross-functional interviews. You will meet with engineering managers, mechanical designers, and operations leaders. This stage heavily features situational and behavioral questions, technical deep-dives into root cause analysis, and discussions about how you handle vendor relationships and machine downtime. You may also be asked to review a technical drawing or a process flow to demonstrate your analytical skills in real-time.

This timeline illustrates the typical progression from initial screening to the final cross-functional panel. Use this visual to pace your preparation; focus heavily on high-level career narratives early on, and transition into deep technical and regulatory review as you approach the onsite stages.

5. Deep Dive into Evaluation Areas

Automation & Controls Engineering

Your core technical competency is the foundation of this role. Interviewers need to know that you can independently design, program, and maintain the automated systems that build Ormco products.

Be ready to go over:

• PLC and HMI/SCADA Programming – How you architect control software for unique manufacturing projects and ensure robust operator interfaces.
• Industrial Vision and Robotics – Your hands-on experience with systems like Cognex or Keyence, and how you integrate them into a production line for quality inspection.
• System Integration – How you tie together servos, lasers, and custom hardware using object-oriented languages like .NET or C++.
• Advanced concepts (less common) – 3D prototyping integration, non-contact metrology equipment, and custom thermoforming automation.

Example questions or scenarios:

• "Walk me through a time you designed and programmed a control system from scratch. What challenges did you face with the PLC integration?"
• "How do you set up an industrial vision system to inspect products with extremely tight tolerances?"
• "Describe a scenario where a robotic cell was failing intermittently. How did you diagnose and resolve the issue?"

Quality Assurance & Process Validation

In a medical device environment, building the machine is only half the job; validating that it consistently produces quality parts is equally important. You will be evaluated on your adherence to strict quality management systems.

Be ready to go over:

• Equipment Validation (IQ/OQ/PQ) – Your methodology for proving that new or modified equipment meets all internal and external regulatory requirements.
• Regulatory Standards – Your working knowledge of FDA regulations and ISO 13485, and how they impact daily engineering decisions.
• Process Failure Mode Effects Analysis (PFMEA) – How you identify potential risks in a manufacturing process before they result in defective products.

Example questions or scenarios:

• "Explain your approach to executing an IQ/OQ/PQ for a newly installed automated inspection machine."
• "How do you ensure that a change to a machine's programming does not violate FDA or ISO 13485 compliance?"
• "Tell me about a time you used a PFMEA to alter a machine's design during the development phase."

Root Cause Analysis & Continuous Improvement

Ormco highly values LEAN initiatives and continuous improvement. When production lines go down or yield drops, you are the technical responder expected to find a permanent solution.

Be ready to go over:

• Troubleshooting Methodologies – Using structured frameworks (like 5 Whys or Ishikawa diagrams) to trace defects back to their origin.
• Downtime Reduction – Working with maintenance teams to improve machine reliability and redefine preventative maintenance schedules.
• Cost Savings – Documenting how your technical interventions improved productivity, reduced waste, and saved the company money.

Example questions or scenarios:

• "Describe a complex manufacturing defect that was difficult to trace. How did you find the root cause and implement a countermeasure?"
• "How have you previously collaborated with a maintenance department to improve overall equipment effectiveness (OEE)?"
• "Give an example of a LEAN initiative you championed that resulted in documented cost savings."

Project Management & Leadership

As a senior or lead engineer, your ability to guide others is just as scrutinized as your technical skills. You must demonstrate that you can manage projects, timelines, budgets, and people effectively.

Be ready to go over:

• Mentorship – How you lead and train teams of engineers, contractors, and production operators.
• Vendor Management – Coordinating with outside suppliers to develop equipment, resolve procurement issues, and hold them accountable to quality standards.
• Cross-Functional Communication – Translating technical automation constraints to product managers or operations leaders.

Example questions or scenarios:

• "Tell me about a time you had to lead a team of contractors to deliver an automation project under a tight deadline."
• "How do you handle a situation where an outside vendor fails to deliver equipment that meets your design specifications?"
• "Describe your process for training production operators on a newly implemented automated process."

6. Key Responsibilities

As a QA Engineer and Automation Lead at Ormco, your day-to-day work is a dynamic mix of floor support, strategic design, and cross-functional leadership. You will spend a significant portion of your time on the manufacturing floor in Pomona, actively monitoring in-line automated processes for the Spark and Ormco production lines. When issues arise, you are the subject matter expert tasked with guiding root cause analysis and implementing immediate, effective countermeasures to ensure production targets are met without compromising quality.

Beyond immediate troubleshooting, you will lead the design transfer and validation of new equipment. This involves collaborating closely with mechanical design engineers and software groups to develop robust, low-risk machine designs. You will write and execute validation protocols, ensuring every piece of equipment complies with FDA regulations and ISO 13485 standards. You will also be responsible for programming the PLCs, HMIs, and vision systems that run these machines, fine-tuning them to handle tight tolerances and complex assemblies.

You will also act as a central hub for continuous improvement. This means working with outside vendors to procure new technologies, partnering with the maintenance department to optimize equipment reliability, and driving LEAN initiatives across the facility. Additionally, you will be responsible for developing standard work documents and training production operators, ensuring that the human element of the manufacturing process is as reliable as the automated systems you build.

7. Role Requirements & Qualifications

To be competitive for this role, you must present a strong blend of mechanical/electrical engineering background and hands-on manufacturing experience. Ormco expects candidates to be fully capable of independent technical execution while possessing the interpersonal skills necessary to lead.

• Must-have skills – 5+ years of experience in automation or process machinery controls design. You must have at least 2 years of proven experience with Industrial Vision Systems (Cognex/Keyence), PLC/HMI programming, and industrial robotics. A Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a related field is strictly required. You must also have experience leading teams or contractors and a solid foundation in 3D CAD software like SolidWorks.
• Regulatory experience – Experience working in an FDA-regulated environment or a similarly strict industry (like Aerospace or Automotive) is critical. You must understand how to navigate compliance documentation and validation cycles.
• Nice-to-have skills – Intermediate to advanced skills in PC programming (.NET or C++). Experience with 3D printing, metal injection molding, or non-contact metrology is highly preferred. Bilingual fluency in English and Spanish is also a strong plus, given the diverse workforce and potential travel to locations like Mexico.
• Soft skills – Exceptional technical judgment, organized thinking under constrained deadlines, and strong interpersonal skills to motivate team members and communicate complex issues clearly to non-technical stakeholders.

8. Frequently Asked Questions

Q: How technical are the interviews for this QA Engineer role? The interviews are highly technical, but grounded in practical application. You will not be asked abstract software algorithms; instead, you will be expected to discuss real-world PLC programming, vision system integration, and how you specifically execute IQ/OQ/PQ validations.

Q: Is this role fully on-site? Yes. The job descriptions explicitly state this is an on-site role in Pomona, CA. Because you are dealing with physical manufacturing equipment, production lines, and operator training, physical presence is required. You should also expect up to 25% travel, including international travel to Mexico.

Q: What is the culture like within the GME team at Ormco? The culture is fast-paced, highly collaborative, and heavily focused on LEAN manufacturing principles. You are expected to be a self-starter who can take ownership of projects from start to finish while maintaining high ethical standards regarding quality and compliance risks.

Q: How long does the interview process typically take? From the initial recruiter screen to the final offer, the process generally takes between 3 to 5 weeks. Scheduling the onsite/virtual loop with multiple cross-functional leaders is usually the longest phase of the timeline.

Q: Do I need to be an expert in both hardware and software? You need a strong foundation in both. While you may lean slightly more toward controls programming (software) or machine design (hardware), you must be comfortable bridging the gap. You need to read mechanical drawings, program PLCs, and understand the physical demands of the equipment.

9. Other General Tips

• Master the STAR Method for Floor Scenarios: When answering behavioral questions, clearly define the Situation on the manufacturing floor, the Task you were assigned, the specific Action you took (e.g., modifying a PLC logic or conducting a PFMEA), and the Result (quantified in cost savings or downtime reduction).
• Speak the Language of Compliance: Always frame your engineering decisions within the context of quality and safety. Mentioning FDA regulations, ISO 13485, and proper documentation practices organically in your answers will score heavy points with the hiring team.

• Showcase Vendor Empathy and Firmness: You will be interacting with outside suppliers frequently. Demonstrate that you can hold vendors strictly accountable to timelines and technical specifications while maintaining a professional, collaborative relationship.
• Highlight LEAN and Cost-Consciousness: Ormco expects you to demonstrate responsibility for the financial aspects of the company. Be prepared to discuss how your engineering improvements directly positively impacted the bottom line.

10. Summary & Next Steps

Securing a QA Engineer or Automation Controls role at Ormco is an opportunity to directly influence the manufacturing pipelines of products that improve millions of lives. The company is looking for a unique hybrid: an engineer who is deeply technical with automation systems, rigorously disciplined in medical device quality standards, and capable of leading cross-functional teams on the factory floor.

The provided salary data shows the target market range for this position. When interpreting this, remember that actual compensation depends heavily on your depth of experience with specific automation tools (like Cognex or PLC programming) and your familiarity with FDA-regulated environments. Leverage your documented cost savings and process improvements from past roles to position yourself strongly within this range.

Your preparation should now focus on refining your narrative. Practice walking through your most complex automation projects, ensuring you can clearly articulate the root cause analysis, the validation process, and the ultimate business impact. Review your knowledge of ISO 13485 and LEAN principles, and be ready to prove your hands-on capabilities. For more insights and shared candidate experiences, continue exploring resources on Dataford. You have the technical foundation required for this challenge—now it is time to demonstrate your leadership and precision. Good luck!