机械/制造 Quality Engineer常见面试问题列表 (偏regulation行业，例如医疗)

Walk me briefly through your career history/progression.


Describe your experience in working within a regulated industry.  (ISO9001, ISO13485, ISO17025, FDA)  Please use examples and provide details of any specific project or compliance work you have performed. (Examples:  acted as lead in gaining ISO13485 registration, responded to FDA form 483 observation etc…)



Can you think of a time when your standard approach to problem solving didn’t produce the desired solution?  What did you do?


Some jobs provide the opportunity to coach and instruct others.  Tell me about a time when you had to coach others and were satisfied with the results.  Why?

. From 1point 3acres bbs

Tell us about an organizational change that you experienced in your career that you feel was not successful.  What made it unsuccessful?  What would you have done differently if you had been responsible for implementing the change?


What types of quality metrics does your most recent employer track?  How was information regarding progress towards meeting metrics disseminated throughout the organization?


Sometimes it is difficult to make an unpopular decision, knowing it is not possible to please everyone.  Tell us about a time you had to make one of those unpopular decisions.  



If we’re lucky, we sometimes can identify and correct a small problem before it becomes a major problem.  Can you give me an example of when you were able to identify a small problem before it became major?



What skills or qualities are important for dealing effectively with internal customers?  Give an example of when you displayed these skills or qualities.


•        SPC (Statistical Process Control) and Process Capability:  
•        Can you describe the difference between Cp (or Pp) and Cpk (or Ppk)?  
•        What is an acceptable Cpk (or Ppk) for process capability?  
•        Is it better to have a higher or lower Cpk (or Ppk)?  
•        Can you tell me about a time when you used process capability statistics or SPC to improve a manufacturing process?  
•        Use Mini-Tab for capability analysis, etc.?  
•        GD&T (Geometric Dimensioning & Tolerancing), metrology, CMM programming:
•        What does a basic dimension on a drawing look like?  
•        Does a basic dimension have a tolerance?  
•        Can you describe how bonus tolerances work?  
•        MMC?   
•        LMC?  

•        Validation per ISO 13485 and/or FDA regulations:
•        What is the purpose of process validation?  
•        Can you describe the FDA requirement for validation?   
•        Can you tell me about a project you worked on where process validation was utilized or required, and the results of this work?   

•        Gage R&R (Repeatability & Reproducibility):  
•        What is the typical acceptable percentage for a gage R&R?   

•        Quality Control Plans:  
•        What is the purpose of a Quality Control Plan?  

•        RC/CA (Root Cause/Corrective Action):  
•        What tools have you used for Root Cause Analysis and Corrective Action?  
•        Can you describe a time when you used at least one of these Root Cause Analysis tools?  

•        QMS Standards (ISO 13485, AS9100):
•        With what Quality Management Systems standards are you familiar?  
•        What is the purpose of having an effective QMS?  

•        Risk management experience such as facilitating and participating in PFMEA (Process Failure Mode and Effects Analysis):  
•        What is the purpose of performing PFMEA?   
•        Can you tell me about a time when you facilitated or participated in a PFMEA?
•        Was your role as a participant or a facilitator?  

•        Manufacturing process experience such as laser welding, cutting, marking, and metal removal (machining) processes:
•        Can you describe your experience level with any of these manufacturing processes?  

•        Customer and/or supplier communication:
•        Have you been in roles where you had customer and/or supplier communication and coordination?
•        Can you describe for me a time when you worked with a customer or supplier to resolve an issue or quality problem and tell me about the results?

What questions do you have for us?

这不是例如医疗，这就是医疗器材企业面试mechanical engineer的题目啊！这些问题看起来更加类似于面Quality Engineer的岗，即生产和供应商相关，而不是研发。

赞一个！看到后面那些题目熟悉的让人心疼！真的很有用，我是行业小白，上班用这些其实也不知道有啥用，看了这些问题平时可以用我们公司的training document自己整理起来了。

先收藏，大家其实可以结合自己的经验来答一答，没想到0102年了还有人找Q&R的工作哈哈。

先收藏了 谢谢楼主

必须马一个，感谢楼主丰富ME类资源

各位有GD&T 的书推荐的吗？ 我上学期学这个学的迷迷糊糊的，感觉以后可能需要。 谢谢各位大佬

好及时，马上能用到，谢谢楼主好人一生平安啊！！

好棒！谢谢lz

总结的真好，多谢！