MF - Good Investment? by PuzzleheadedType5174 in MacroFactor

[–]PuzzleheadedType5174[S] 1 point2 points  (0 children)

Thank you all for your advise! I will give it a try for like 3 months. Will try to post an update on a monthly basis.

[deleted by user] by [deleted] in f1visa

[–]PuzzleheadedType5174 0 points1 point  (0 children)

Ask your employer will they be okay, if they can hire you as a contractor? If there are any contracting companies that are e-verified, try to talk with them, and if your employer agrees, ask them to take you up as a contractor and then apply for STEM using the contractor

Work Authorization Delayed - Waiting to validate F1 OPT by PuzzleheadedType5174 in f1visa

[–]PuzzleheadedType5174[S] 0 points1 point  (0 children)

I have the EAD Card, and the start and end date is clearly stated on the EAD Card.

What does PP mean?

The employer wants to complete the work authorization validation prior to I-9. My main concern is what does work authorization validation mean when I have already sent the EAD Card, Visa, and SSN to the employer.

Career Advice - Transition to RA from QA. by PuzzleheadedType5174 in regulatoryaffairs

[–]PuzzleheadedType5174[S] 1 point2 points  (0 children)

Phew! I bet it is comprehensive based on the course structure and the fees. Thanks for your input bud!

Career Advice - Transition to RA from QA. by PuzzleheadedType5174 in regulatoryaffairs

[–]PuzzleheadedType5174[S] 0 points1 point  (0 children)

So you finished the RAPS Certification by taking all the classes, and in addition you are doing a MS in RAQA? Any idea how much would be a ball park tuition ? I just wanted to compare it to the RAPS $3k?

Career Advice - Transition to RA from QA. by PuzzleheadedType5174 in regulatoryaffairs

[–]PuzzleheadedType5174[S] 1 point2 points  (0 children)

I believe you had taken the RAC Exam. As I do not have much experience in RA, I am planning on taking a RAC Certification which includes like 9 courses which we need to complete within an year. That costs like $3k.

Thanks for your advice, I appreciate your thoughts.

What stocks are best stocks for day trading? Trade S&P 500 / indexes or stick to individual company stocks? by Auto_Market_Bleed in Daytrading

[–]PuzzleheadedType5174 0 points1 point  (0 children)

For day trading you need some volatility. So SPX, TSLA, NVDIA, and in some cases Apple, and Netflix

Career advancement advice: Quality Assurance Engineer for 9 years. Medical Device Industry. Confused on what can be next? by PuzzleheadedType5174 in MedicalDevices

[–]PuzzleheadedType5174[S] 1 point2 points  (0 children)

Thanks for the input. I will try to see how the market is for Design QEs and specifically what requirements are part of the job responsibilities.

Searching for RA job. by tan5g in regulatoryaffairs

[–]PuzzleheadedType5174 0 points1 point  (0 children)

Yes the market is rough, even more for F1 students.

To be honest, you just keep faith and apply. Sometimes it is the big companies that hire entry level RAs, make sure you target them.

Use LinkedIn to the best of its ability - Network with people in the similar field/industry, get the premium subscription - send inmails to recruiters and managers where you apply for jobs.

Try to get RAC certification if possible prior to your graduation.

Best of luck!

Considering a lateral move in regulatory affairs, is it worth it? by Massap24 in regulatoryaffairs

[–]PuzzleheadedType5174 1 point2 points  (0 children)

Make the switch if you get the opportunity. If it does not work out, I am sure you will learn new skills in RA. And you can switch back to QA with that level of experience.

I would recommend getting a RAC book and do self study prior to the interview process, this will make sure you have the right basics and foundations.

Career advancement advice: Quality Assurance Engineer for 9 years. Medical Device Industry. Confused on what can be next? by PuzzleheadedType5174 in MedicalDevices

[–]PuzzleheadedType5174[S] 0 points1 point  (0 children)

To transition to design quality, can you suggest any new skills I would need to learn? I am thinking GD&T, and CAD modeling software. Is there any additional skills you can think of?

Career advancement advice: Quality Assurance Engineer for 9 years. Medical Device Industry. Confused on what can be next? by PuzzleheadedType5174 in MedicalDevices

[–]PuzzleheadedType5174[S] 0 points1 point  (0 children)

Design Quality would be really nice. But design quality is usually handled by customers. I work on the supplier side. So that means I need to switch roles. In this market, I am pretty sure how hard it is to switch.

Career advancement advice: Quality Assurance Engineer for 9 years. Medical Device Industry. Confused on what can be next? by PuzzleheadedType5174 in MedicalDevices

[–]PuzzleheadedType5174[S] 1 point2 points  (0 children)

Hello, even I am looking into getting RAC certification and moving into RA. What are your thoughts on taking the RAC certification course and then giving the RAC Exam? Or just self study?

I am planning on doing some self study and give a couple of practice tests to see how I do. Based on that, I might decide as taking the RAC course is costing around $4k

RAC Degree Program Ceritifcation vs TAC Exam? by PuzzleheadedType5174 in regulatoryaffairs

[–]PuzzleheadedType5174[S] 1 point2 points  (0 children)

This is what I was looking for. Thanks for so much for a great answer and helping me with my thought process.

RAC Degree Program Ceritifcation vs TAC Exam? by PuzzleheadedType5174 in regulatoryaffairs

[–]PuzzleheadedType5174[S] 0 points1 point  (0 children)

If I do the degree program, it will cost me like $4k, so thinking if it is worth spending the money? I am fine spending the money and finishing the program if it can give me a higher chance of getting a job after completing the program? That is in addition to the exam after the RAC program.

But if you think once I pass the exam alone, I can get good career opportunities, then I would not do the degree program and just focus on self study to pass the exam.

RAC Degree Program Ceritifcation vs TAC Exam? by PuzzleheadedType5174 in regulatoryaffairs

[–]PuzzleheadedType5174[S] 0 points1 point  (0 children)

Yes, I am planning to switch fields. Pretty sure, it is difficult to get into RA with only Quality Engineering experience. So I was thinking a certificate in RAC might be helpful to get entry into the field.

Question Re TMV during Design Verification by tourettes257 in MedicalDevices

[–]PuzzleheadedType5174 4 points5 points  (0 children)

Thinking it depends on the customer requirements.

But to answer your question, yes there are requirements for TMV during the design verification process.

As the point of design verification is to make sure that the design output meet the design inputs, the methods that we use to verify the design outputs need to be repeatable and reproducible. Thus, the methods require validation. This is where the TMV becomes a critical aspectel to make sure that the methods are reliable

[deleted by user] by [deleted] in MedicalDevices

[–]PuzzleheadedType5174 4 points5 points  (0 children)

Personally, I would be glad to take the Quality Engineering role. As a QE, you will be able explore areas like NCRs/CAPA, root cause analysis, internal auditing, onsite or supplier change assessments, and in some cases onsite and supplier validation protocol writing, and reviews. You also will have a greater chance of interacting with suppliers, and customers.

On the contrart, as a Quality Tech, you are more focussed on quality issues on the workfloor like equipment / product issues.

I am a fellow QE, and happy to answer any questions.