SENIOR QUALITY ASSURANCE ENGINEER (QA/RA)

We need to strengthen our quality team with another senior team member in the MedTech area. Could it be you?

Do you want to be part of ensuring that new groundbreaking technology in MedTech reaches the market in a quality-assured and regulatory-correct way?
Right now, we are looking for you who want to be involved in developing products that make a real difference in people’s everyday lives. Imagine an everyday life where your knowledge of MedTech creates quality-assured solutions for innovative customers around the world. This everyday life can be yours!

What would your new everyday life entail?
It is a broad QA/RA role that OIM wants to fill, which means a flexible and exciting position for a driven QA/RA engineer. Above all, we want you to be involved in ensuring that quality work becomes a natural part of our product development process.
You will work with developing, building, and reviewing quality systems within ISO 13485 and QSR. Drive investigation and implementation of corrections against deviations & CAPA. You act as an advisor in the organization on MedTech issues.
In our development projects for products or systems, you get to be involved in setting up the project structure and being a driving force in the production of the necessary documentation, such as validations of instruments, methods, equipment, and processes where applicable. Requirement documents, specifications, and risk analyses are also important elements in our projects where we want to achieve a high level of quality in the work performed.

Annual review of existing regulations and gap analyses against new ones are also areas where we want a QA/RA engineer to take the lead.

When we work with the production of products, the tasks may consist of reviewing, evaluating, and releasing products to our customers.

In the area of purchasing, day-to-day operations can consist of supplier assessments, internal and external audits, and annual reviews.

For us, strict requirements and regulations, together with solid quality assurance, are an extremely important component when working in the MedTech field. With our ISO 13485 certification, we cover both development and production in Life Science. We are used to working on technology-heavy projects where efficiency and tight schedules are crucial factors.

As part of the in-house team at OIM, you always have access to our collective expertise and to our premises that house labs, prototype workshops, production areas, etc.

About you
We believe that you have at least 5-6 years of work experience in quality and regulatory work and that you are passionate about working with product development for real. Your knowledge in MedTech is very good and you are driven by teaching and sharing your knowledge with the rest of the team. You have experience working with either ISO 13485 or ISO 14971.

Curious?
If you have any questions or concerns, Peter Norrman is just a call away at 0766-10 19 59 or by e-mail.
We hope to be able to show that what we do is real and create a new everyday life for you.