Quality Assurance Engineer
What does a Quality Assurance Engineer do at OIM?
As a Quality Engineer or Quality Assurance Engineer, you work, among other things, with performing risk management of an upcoming or existing product. You are an essential piece of the puzzle in the work of quality assuring the product development process and products that you develop.
You write, update and review internal and customer documents that are required for e.g. electrical, EMC tests, or CE marking. The risk and user requirements ensure that there is a detailed requirement and traceability between them.
It also makes sure to keep abreast of the authorities’ current regulatory requirements and directives regarding medical devices. You update technical documentation, the documentation required to contribute to CE marking, and participate in risk assessments.
What makes a QA Engineer different from an RA Engineer?
An RA Engineer should be interested in reading regulations and standards. The tasks are largely about moving/updating routines that govern the business. You are out checking, following news, and continuously updating yourself with new standards and regulations in the world that may apply to the particular product you are working with at the time.
A QA Engineer works more with risk/requirements management and review of product documentation. Routines and requirements set in the various projects are updated.
Three quick questions
We asked three quick questions to Eva Hansen, our QA & RA Engineer at OIM Sweden AB.
Any dream project?
My dream project is about a product that involves both chemistry, biology and medicine which are my specialist areas and it is such a project I am working on right now. Really fun and challenging!
What programs do you use?
At OIM we have a paper-based QMS system but there are different electronic platforms. We often get to work in customers’ QMS systems. Otherwise, there is a lot of work in the Office package, such as Word, Excel or PowerPoint.
What projects have you worked on?
I have worked on three different exciting MedTech projects. One in virus detection, another in cancer diagnostics and treatment and the third in robotic medicine. Some really exciting projects that in different ways will make a big difference for people.
What do you need to study to become a QA Engineer?
As far as I know, there is no pure education that makes you become a QA Engineer, but I have continuously attended various courses to learn relevant standards and regulations. You can also join networks for people who work with quality and then offer them ongoing training that is very useful in the role of QA Engineer.
Since there is a shortage of QA Engineers and a high demand, there are many jobs available. It's an attractive profession!
Oskar Karnehall, Verification and Validation Engineer at OIM Sweden AB
Oskar Karnehall, Verification and Validation Engineer at OIM Sweden AB
What distinguishes OIM from other companies you have worked in?
At OIM, you work with many different employees in different disciplines who do not have the same knowledge in quality work and who then need advice and training.
The role here becomes more educational and a lot is about relationships, both with everyone involved in the project internally and also with customers. It is extra stimulating to work as a spider-in-the-web as an advisor and train all the wonderful colleagues to become even a little sharper on regulations and standards.
You also get to be involved in labeling, IFU, and tests to see that the product lives up to the different standards that exist for different products.
Eva's top five tips for becoming a better QA Engineer
As a QA person, you should like order and be something of a structured person
Be curious and make sure to keep abreast of the relevant standards
It is good to be able to understand the risks of different subject areas, such as how mechanics and electronics affect each other
Try to be involved in the entire project from start to production, it gives an even more qualitative work
It is a great advantage if you like to follow standards, regulations and have a great interest in risk management
ISO 13485-certification
OIM’s product development process places high demands on complying with the medical device regulations or other regulatory/customer requirements as well as the ISO 13485 standard. An ISO certification contributes to order, structure, and systematics that ensures that nothing important falls between the cracks in, for example, a product development project from idea to finished product.
What is risk management?
In risk management, you start from a product standard to identify any risks and see which risks are relevant to the particular product you are going to develop, and then you set a requirement that you need to follow.
Anything else you'd like to share with our readers?
Being a QA Engineer is a really fun role where I am driven by finding the best solution to facilitate the customer’s everyday life. There are lots of exciting companies to work with and right now the demand for QA Engineers is high and there is a shortage of skills, so there are many jobs out there. You do not need to work with Medtech products, but quality work is all products that must comply with a directive or regulations.
Do you want to work as a Quality Engineer?
Find out if there are any vacancies or call us at +46 40-13 13 69. Below is a form you also can use to contact us!