Q. Where do you currently work?
A. I work at Edwards Lifesciences in Irvine, California. We specialize in therapies for critically ill patients suffering from acute heart problems, such as failed heart valves.
Q. What is your role at Edwards?
A. I am Staff Quality Engineer, at our Heart Valve Therapy division. I currently support our heart valve manufacture, primarily involved in day-to-day manufacturing support, such as non-conformances, engineering change requests, and the typical manufacturing fire-fighting. I'm also heavily involved with quality and yield improvements, equipment and process validations, test method validations, failure root-cause analysis, and Failure Mode and Effects Analysis.
Q. What is a typical day like for you on the job?
A. Hectic! I usually have three to four improvement projects that I work on simultaneously, in addition to ensuring that the manufacturing lines are running smoothly. I sign off on numerous non-conformance reports, validation protocols, validation reports, and chasing down signatures for my own engineering change requests (giving that we have a large campus with 4 different buildings, this usually gives me a good 30 minutes of brisk walking exercise every day, a little fringe benefit). In addition, we typically have 2-3 hours of formal meetings every day, not counting all of our informal cubicle meetings. I try to have my day about 50% planned in advance, leaving the rest for the unforeseen (which always happens in manufacturing).
Q. What skills are necessary to be successful in your job?
A. 1. People Skills!
There is no substitute for the ability to professionally interact with all levels of co-workers, from the custodian cleaning our restrooms all the way up to the CEO, who may be male or female, American (any hyphen), Vietnamese, Persian, Jordanian, Israeli, Puerto Rican, Mexican, Laotian, Cambodian, Korean, Singaporean, Swiss, Indian or Japanese, just to name a few. These people may also be Christian, Moslem, Jewish, Buddhist, Hindu or Agnostics, makes no difference. Almost all of my work is team-based (either as team leader or member), and in order to be successful in this type of environment, one needs to be both sensitive and professional, and always be mindful of the accepted corporate behavior. Mind you, this is not a negative; instead it fosters a high level of professionalism and focus on the objectives, while building strong networks for future interactions. I always tell the new engineers coming in that "e-mail does not work, you need to go see these people, introduce yourself, learn a few things about them, and continuously work on the relationships. You never know who you will be working for, with, or who will be working for you. Keep your nose clean at all times!"
2. Flexibility!
I have been at Edwards for a little more than 3.5 years, and during this time I have had 7 different cubicles in three different buildings, and 5 different managers. Learn, adapt, change, try to create your own flow, but don't try too hard to swim upstream.
3. Integrity!
Always try to do the right thing for the ultimate customer, the patient who is in need of our life-saving and live-sustaining products. When something is obviously wrong, argue your case with passion and conviction, just make sure that you are right! Be honest, and own up to your own mistakes. Always praise the efforts of others, while down-play your own. Praise in public, scold in private.
4. Good Solid Writing Skills!
I do a lot of technical writing; test protocols and reports, technical summaries, engineering change request justifications and training slides, all in English. The expectation is that any of my documents can be audited by the FDA and/or an ISO organization, so the writing must be very clear, concise and persuasive.
Q. What do you like most about what you do?
A. This is taken from my Preface of my Master's Thesis (Quality Assurance, CSU Dominguez Hills), which is pretty much my current view:
"I cannot think of a more gratifying career than to work with medical devices. To think that the products that I'm involved with help patients to ease their pain, restore their health, and save and prolong their lives is truly a humbling and satisfying thought. Also, I have been, and continue to be, blessed to work with some truly brilliant people. However, we must never forget that we work in a regulated industry, and as such we must continuously be on guard to ensure that we conduct ourselves with the outmost integrity and ethics. Above else, do no harm."
As you can see, there are three components that I find truly satisfying:
Working with products that save and prolong lives
Working with and learning from some very smart people.
Working in the regulated medical device industry.
Q. How did you end up working at Edwards?
A. I started working in medical devices in November of 1997, at small contract manufacturer called Horizon Medical, where we had a few Baxter alumni (Edwards Lifesciences spun off from Baxter in 2000). In late 2001 I was laid off, and applied at Edwards Lifesciences (for the first but not last time). I had a formal interview with Edwards in the summer of 2002 (did not get the job); some phone interviews in 2004, and two sets of interviews in 2006 (June and November). I finally got hired, and started at Edwards in January of 2007. In one word, persistence! I had been sending Edwards my updated resume every 6 months or so, so after some 5 years of trying, I finally got my wish, and I have never regretted accepting the job offer from Edwards.
Q. Why did you choose to go into QA?
A. Accident, Fate, Serendipity, take your pick! I was working as a manufacturing engineer for a medical device start-up in 2004, and we were attending a seminar on Risk Management. If you were an ASQ member, you got a $200.00 discount on the seminar, and the membership was something like $130.00, so we all thought that saving $70.00 was a good deal, and we became ASQ members (section 701, Orange Empire). From there, since I was heavily involved with regulatory compliance in our efforts to obtain our ISO 13485 medical device certificate, I started attending ASQ Certification classes, primarily since they were held at Alcon in Irvine, which was on my way home. I got my CQE, Certified Biomedical Auditor, and my CSSBB from ASQ while still working at the start-up. With that in my back-pocket, it was quite easy to make the transition into quality, especially since I had performed many of the typical QE functions at the start-up. When Edwards called me in November of 2006, they needed somebody that was familiar with CAPA (Corrective and Preventative Actions), and also familiar with regulatory compliance, and I was offered the job of "Compliance Specialist.".
Q. What is your educational background?
A. From my resume:
Master of Quality Assurance, CSU Dominquez Hills, December 2009
(Paid for by Edwards through their generous Educational Assistance Program, thanks Uncle Eddie!);
Master of Business Administration, CSU Fullerton, June 2004;
Bachelor of Science, Chemical Engineering, CSU Long Beach, December 1996;
Associate of Science, Natural Science, Irvine Valley College, June 1993.
Q. How did your education play a role in where you are now?
A. An Incredibly important role, and completely integral to my current career! Edwards, being a very successful and profitable $1.4 billion company, have the pick of the best and the brightest. Without a solid education, I would have had no chance of being hired. I truly believe that it was a combination of having an MBA and being an ASQ Certified Six Sigma Black Belt that finally got me the job at Edwards, in addition to 10 years experience. Most of our young engineers that come in are recruited from big name schools like Duke, Purdue and Stanford, and many already have their masters at the age of 23-24. However, we also have a smattering of kids from the UC schools such as Berkeley and UCI; unfortunately it appears that the Cal State schools are a bit underrepresented, something that needs to be rectified. However, being completely dedicated to the Cal State system myself, I believe that my education is every bit as strong, especially my MBA from Cal State Fullerton, which in my opinion is a world-class business school.
Q. What are your near-term and long-term career goals?
A. Stay employed in the medical device industry for the next 20 years! I have had both engineering and management experiences, and I seem to like the technical side a bit better than management. Consequently, I'm planning to stay working as an engineer in the field, as a QE, Manufacturing Engineer, or R&D Engineer. However, at a large company like Edwards, there are many great opportunities, and I will go where the interesting and satisfying work is, be it engineering or management. Incidentally, many of us engineers have or have had direct reports, while continuing in our engineering capacities, it goes back to being flexible. Nevertheless, there has to be some technical challenges in my work, otherwise I get bored.
Q. What advice would you give to students and professionals currently in the life sciences industry considering a career in QA?
A. Jump to it! I think everybody in the medical device industry should serve a stint as a Quality Engineer or Quality Manager, it is a very enriching experience, and builds character. I also think that just about every engineer in medical devices should be an ASQ Certified Quality Engineer, and Biomedical Auditor. Throw in the Six Sigma Black Belt, and you are ready to jump in. Also, the Masters program in Quality Assurance from CSU Dominquez Hills (online), is a great program; very accessible, affordable and comprehensive. Just recently they have started to offer a greatly enhanced program with the medical device industry in mind, under the great leadership of Dr. Milton Krivokuca.
Q. Is there anything else you would like to mention?
A. When I transferred to CSU Long Beach in 1993, the professor giving our orientation said something quite profound:
"There are two kinds of universities, those that are hard to get in to and easy to get out of, and those that are easy to get in to, and hard to get out of."
CSU Long Beach proved to be just that; not that difficult to get in, but, as a Chemical Engineering Student, hard to graduate from. The classes were very difficult, the curriculum very comprehensive, and no coddling of the students. Either you have what it takes and can graduate from a Cal State school (smarts, determination, independence, moxie and networking skills), or you better find some cushy little private university that will hold your hand (and take all your money), and guide your every academic move. I will never regret having chosen the Cal State System for my education; I believe that I'm a much better engineer, co-worker and person for having made that choice. A great educational institution!
Field: Quality Assurance
Job: Staff Quality Engineer-Compliance Specialist
Company: Edwards Lifesciences
