medical device quality engineer interview questions

Quality engineers test and monitor an organization’s procedures and output, find and fix flaws, and implement quality assurance control systems. The ideal applicant will be highly analytical with strong problem-solving abilities. Be wary of candidates with poor project management skills.

Top 25 Quality Engineer Interview Questions and Answers for 2022

Interviews for Top Jobs at Medtronic

Quality Engineer Interview

Application

I applied online. I interviewed at Medtronic

Interview

no heads up before making a phone call for the interview. It was the hiring manager called me without any notice and it is in the middle of the regular business hours. lack of politeness while asking questions. while giving an example the hiring manager said stop giving examples, which was very rude. He called for Full time position but asked me if I can work contracting. Even If I got an offer I would have rejected it.

Interview Questions

  • everything in Job description. Too many to say !

Quality Engineer Interview

Application

I applied through college or university. The process took 1 week. I interviewed at Medtronic

Interview

Met them at my school career fair and was notified about an interview within a couple days. The interview was fairly simple with general behavior questions. It was mainly about the experience I had listed on my resume.

Interview Questions

  • How did you go about solving this problem?

Quality Engineer Interview

Application

I applied through an employee referral. I interviewed at Medtronic (Hyderābād) in Apr 2019

Interview

Usually, it will be 2 rounds of technical review (sometimes 1) and a senior Manager meeting to finalize before having the HR discussion. The process will be smooth and HR is supportive

Interview Questions

  • Experience in quality assurance of medical devices with a handled product example, design controls, and risk management

6 Quality Engineer Interview Questions and Answers

What were some of your quality control procedures in your previous place of employment?

Familiarity with standard procedures in the field are mandatory in a potential candidate. You want your quality engineer to know how quality tests work as well as how material-specific monitoring works, and there may be any number of additional responsibilities that you may want them to stay on top of. Things such as quality-oriented training procedures and quality-specific customer services can all be invaluable, especially if you are thinking about expanding your operations.

What to look for in an answer:

  • Familiarity with standard quality control systems and procedures
  • Additional background in quality-control staff training
  • Ability to delegate related tasks

Do you have experience working directly with customers and their products and resolving potential issues that they may encounter?

Depending on the specific operations that you have planned, it is a good idea for you to work with a quality engineer who can speak with your clients directly. Businesses that specialize in specific products can have their quality engineers speak with the customers directly and take their feedback into immediate consideration. If the candidate is able to do this, then he or she can be a tremendous asset for your business.

What to look for in an answer:

  • Experience working with clients directly
  • Ability to efficiently handle customer criticism
  • Ability to redirect customer feedback to the appropriate channels

Quality engineers use different kinds of tests to determine how their systems will behave under different conditions. They use this information to determine how various circumstances could impact the quality of their products or workflows. Successful quality engineers know when to implement various tests and what to look for in the results to improve operations. This question informs the interviewer about a candidate’s familiarity with common performance tests and their understanding of how they impact quality assurance.

Some elements of a successful answer are:

  • Project management skills
  • Logical thinking
  • Knowledge of quality analysis testing types

This response emphasizes the candidate’s experience with running tests as part of the development process:

Are you comfortable with calling together meetings to discuss specific product quality issues as necessary?

In the event of an emergency, a quality engineer may need to speak with the rest of the team regarding certain quality control issues. In some environments, this is not even done in an emergency. A good candidate should be comfortable with public speaking and collaborating, especially as a part of a weekly or monthly report. Knowing that the potential candidate has experience in this field can be invaluable.

What to look for in an answer:

  • Experience with public speaking
  • Experience addressing quality control issues in the past
  • Ability to adhere to the company’s meeting etiquette

Have you ever had to deal with somebody not following quality standards? What did you do to resolve the situation?

This question is vital, as it offers insight into the candidate’s character from a managerial and departmental perspective. You can learn more about how the candidates would lead if they are in charge of training or how they may help uphold the culture of the workplace with their peers. Look for quality engineer candidates who display diligence and responsibility in making sure that their peers are up to standard.

What to look for in an answer:

  • Exhibition of initiative in stressful situations
  • Understanding of the required quality standards
  • Holds others to the required standards to maximize safety

What is a Project Quality Plan, and why is it so important to have one made efficiently?

This is a vital question that any quality engineer should be able to answer. The Project Quality Plan is one of the most important documents that all staff members should stay on top of in any production or construction project. It is essentially the guidelines of the project, as it establishes a number of deliverable materials and standard work procedures. Don’t work with a candidate who cannot identify a PQP.

What to look for in an answer:

  • Understands the importance of a PQP
  • Knowledge of what goes into its development
  • Ability to decipher the information within as required

Can you describe a recent project in which you successfully implemented quality control procedures?

Reveals specific work experience and achievements.

Interview Questions for Quality Engineers:

Demonstrates interpersonal and problem-solving skills.

Can you describe how you investigate production flaws?

Illustrates analytical and troubleshooting skills.

Quality Engineers Interview Questions (With Example Answers)

Any industry’s process for developing, producing, and deploying a good or service begins with an idea and culminates in a tangible product for the consumer. If everything goes as planned, the product or service will perform as intended.

However, this is rarely, if ever the case.

Adjustments are frequently required along the way to fix errors that are found. Many businesses set up an architecture of plans and procedures that monitor the product’s life cycle and maintain its quality to reduce the possibility of faulty products.

This architecture is known as quality engineering.

These positions are hiring now close to you if you’re looking for work:

Quality engineering (QE) is very much like quality assurance (QA). In fact, some industries and businesses use the names interchangeably.

However, for the purposes of this article, we will focus on two crucial traits that set quality engineers apart from other members of the quality occupations.

  • QE is treated as an engineering field. This means it relies on scientific principles to build a rational system of quality oversight. Data and applied mathematics are analyzed heavily. This allows for quality to be predicted, recorded, and perfected in a logically organized way.
  • Whereas someone in QA may be involved in strictly planning or testing, members in QE are expected to understand all levels of the process from development to release. This means in QE you will know the intricacies as well as the overall vision for the product which empowers you to make rational decisions.
  • Like other engineers, a QE’s analytical and critical thinking abilities are valued. These abilities are used by a QE to create, put into practice, and test methods for evaluating and approving the product quality. The QE is expected to collaborate with management, production, and even customers because they possess extensive knowledge.

    Large companies may assign you a specific role within QE, but in order to stand out as a candidate, you must demonstrate that you are aware of the various dynamics of the position.

    You must be equipped as a QE to deal with each stage of the product lifecycle and the various affected groups. If you intend to attend an interview for a position as a quality engineer, you should be ready for a variety of questions that will gauge your understanding of the position and its function within the product life cycle.

    To aid in your comprehension of the role, read through the examples of QE questions and responses provided below. Examine how the questions differ from your expectations to determine where you may need to make improvements.

    11 Examples of QE Questions And Answers

  • How would you describe quality engineering? This question tests both your knowledge of QE and your communication skills. Assume your interviewer does not know the specifics of QE and speaks in such a way that most professionals would understand. Avoid jargon but also do not be vague. Convey your idea with an assertive approachability. Example Answer:

    “Quality engineering is a philosophy that merges engineering principles, such as using logic and data analysis, with quality implementation. The documentation and rational structure of quality engineering allow for a better understanding of quality that can be further studied and perfected.”

  • What are the responsibilities of a quality engineer? The job description will tell you the responsibilities of the QE position, so reiterate what is written. If time allows, go further and expand your answer to cover the role QE plays within a company. Highlight how you understand QE is beholden to many stakeholders. Example Answer:

    “I know that my day-to-day responsibilities would include monitoring the test results of the sampling procedures, as well as preparing contingency plans for possible errors. I believe it will also be my responsibility to make myself available to members of the management, production, and customer relations teams to supplement each other’s expertise.”

  • Tell me of an experience you dealt with a difficult customer or client. What happened? How did you resolve it? QE can include customer interaction. Your customer service soft skills are just as important as your analytical hard skills. Answer this behavioral question in a way that shows your effective professionalism. Example Answer:

    “When I worked at an IT help desk, I often dealt with customers who were frustrated with our product’s instructions. Once I dealt with a rude customer who threatened me, but I remained calm. I had prepared a simplified version of our instructions which I emailed to the customer and offered to stay on the phone while they worked out the new directions.”

  • How do you feel about working on a team? QE deals with many different stakeholders such as design teams and suppliers. Also, you may be a member of a QE team. In any case, you should be ready and willing to work with others. Example Answer:

    “I enjoy working on teams. I find it very constructive to weigh differing ideas for problems and solutions. For a team to succeed the goals should be clear and channels of communication polite and direct.”

  • How would you assert a change needed to improve quality? Though a QE is expected to provide solutions that improve quality, other stakeholders in the production process may disagree on what is required. You have to convince others professionally. As a QE you must be able to be tactful yet firm on issues of quality. Example Answer:

    “As long as I had the data to back up my argument, I would be assertive by contextualizing the need for change. I would show how the change would be a positive benefit for the company. I would listen to feedback but unless they provided a rational counterargument, I would maintain my position.”

  • What is the importance of a project quality plan? The project quality plan, also known as the quality management plan, details the processes and standards that will define a quality product. It is the central tool for any QE, for without the guidelines there would be no rationale for the actions of a QE. Example Answer:

    “The project quality plan is the backbone of the quality process. It contains how quality will be achieved with specific steps in production along with certain metrics and other deliverables that act as standards for quality. The project quality plan guides quality engineers from start to finish.”

  • What do you know about the American Society for Quality? The ASQ is a nonprofit organization that promotes quality tools and ideas for all businesses. It provides certifications, training, and publications. Companies rely on the ASQ to improve their quality systems. You will likely have to deal with the ASQ at various points in your career. Example Answer:

    “The American Society for Quality acts as a guiding member of the quality community to ensure that the best practices and standards are met. Their certifications help raise the standards of a company’s production process. To remain competitive it is important to consider the ASQ when designing project quality plans.”

  • What do you know about the International Organization for Standardization’s (ISO) 9000 series? The ISO is made up of 165 national standard organizations that work to create an international set of specifications for standardizations in all facets of the economy. This includes quality management. The ISO 9000 series lists the fundamental concepts and principles of quality management. Example Answer:

    “The ISO 9000 series helps quality engineers make sure theyre using internationally standardized practices for quality processes. It includes best practices as well as validations. The standardization of the ISO 9000 series allows a company to work with multiple global partners.”

  • What do you think is the biggest challenge a quality engineer faces? This is a question that is left to your interpretation and you will be judged based on your thought process. If you are serious about QE and have done your research, you will have several options to choose from. Pick a valid issue that you are passionate about. Example Answer:

    “I think the biggest challenge a quality engineer faces is dealing with the fast-paced changes of the modern economy. New ideas are always blossoming however they may not always be practically implemented. A quality engineer needs to maintain a balance of being methodical while also flexible to ever-changing demands.”

  • What would you do if you learned production had to be stopped immediately? Particularly in manufacturing, a halt in production can be a huge problem. Depending on the workflow, a halt could cause a backup or else damage the supply chain. Therefore, if production needs to be stopped, there needs to be a good reason. Example Answer:

    “Stopping production is never easy. It affects people both inside and outside the company. However, as a quality engineer, I have to ensure a quality product is shipped. I would act if something endangered people or if left alone would do more damage than if confronted immediately.”

  • Where do you want to take your quality engineering career? This is like the five-year question. The interviewer wants to know what your long-term goals and plans are because a career in quality engineering is a commitment. Companies invest in candidates who show dedication to the role. Example Answer:

    “Eventually I would like to get a management role in quality engineering. I am interested in using my knowledge to lead teams and build more efficient and effective quality systems. I also like to work alongside other departments to hear everyone’s voice in the process.”

  • The most important thing is that you openly discuss your ideas with your boss, explain your stance, and attempt to reach a consensus decision together. Additionally, pay attention to what they have to say so you can possibly compromise. When under pressure to make a decision, be sure to carefully consider the factors that led you to that decision before making it.

    If you do not have the necessary experience, you must demonstrate to the employer that you possess the necessary skills, qualities, and knowledge to put you on par with those who do. It’s also beneficial to mention how quickly you can learn the procedures of a new job role.

    Answering this question correctly is extremely important because most companies employ professionals with a variety of personalities and traits. You don’t want to appear as though you’ll be interacting poorly with any current employees of the company. If you complain about something insignificant, you’ll come across as a whiner. On your list of personal qualities of people you can’t work with, only betrayal of the organization or breaking the law.

    Select a response that demonstrates your capacity to confront a challenging circumstance head-on in a constructive, positive manner and to let nothing stand in the way of achieving your goals. A great strategy is to discuss your go-to stress-reduction techniques (such as making the world’s best to-do list or pausing to take 10 deep breaths) and then share an instance of a stressful situation you handled expertly.

    When it comes to warehouse operations, it’s crucial to perform work to the required or established standards.

    FAQ

    How do I prepare for a quality engineer interview?

    Quality Engineer Interview Questions
    1. Do you feel at ease setting up meetings to go over specific product quality issues as they arise?
    2. What were some of the quality control practices you used at your previous job?
    3. Have you ever had to deal with someone who didn’t uphold standards of excellence?

    What does a quality engineer do in medical device?

    The quality engineer uses best practices from the quality control industry to make sure that the products produced by the processes, materials, and manufacturing methods are of high quality and dependability. They examine the design history file and any process or design changes for potential effects on quality.

    What are the questions asked in QC interview?

    30 Interview questions for quality control professionals
    • Why do you want to work in quality control?
    • How did you hear about quality control?
    • When do you believe QA for a product should begin?
    • What are your greatest skills that relate to quality control?
    • What are your short-term career goals ?

    How do I prepare for a medical device interview?

    If you want to ace your next medical device sales interview, here are six ways you can stand out from other candidates for all the right reasons.
    1. Use your research skills. …
    2. Start a dialogue. …
    3. Show you are a team player. …
    4. Be honest about your areas for growth. …
    5. Highlight key wins. …
    6. Nail the follow-up.

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