ISO13485, QSR, MDR, ISO14971, IVDR, and FDA

Do these words make you dream or feel like a nightmare?

If it’s your dream, we have the perfect job for you, where you get to make a difference in other people’s daily lives.

OIM could be classified as a scale-up company, where each employee’s knowledge is very significant, and everyone’s contribution counts in our journey to create world-class product development. The team consists of personalities and people, and we are allowed to be ourselves. Our strengths result in innovative ideas becoming products that reach the market quality-assuredly. We have an open and permissive climate and gladly help each other to achieve the best results.

As our new QA/RA engineer, you will be part of the quality and production team, which consists of Eva Hansen, Linn Wrangmark, and Peter Norrman. Does it sound interesting? More info is available in the ad, or you can contact us directly to see if we are a match for each other.

SENIOR QUALITY ENGINEER MEDTECH (QA/RA)

Your future adventure with us involves this: This QA/RA role is for those who want to be part of the product development process by actively participating in QA/RA-related issues in our development projects. It means a flexible and exciting position for a driven QA/RA engineer where no two projects are alike. Since OIM develops products on behalf of our customers, one moment you will be working with a single-use product related to MDR, and the next moment answering questions regarding a multiple-use IVDR product.

You will also work on developing, building, and reviewing OIM’s quality system within ISO 13485 and QSR. You will drive investigations and implement corrections for deviations & CAPA. You act as an advisor within the organization on MedTech issues but also regarding other CE markings.

In our development projects for products or systems, you get to be involved all the way from setting up the project structure, and driving the creation of necessary documentation such as requirement documents, specifications, and risk analyses, which are important elements in our projects where we aim to achieve a high level of quality in the work performed. When the projects are nearing their end, the validation of instruments, methods, equipment, and processes, where applicable, will fall within your area. You will also be involved in supplier evaluations and verification of incoming components.

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

What we are looking for: We believe you have at least 5-6 years of work experience in quality and regulatory work and are passionate about working with product development for real. Your knowledge of MedTech is very good, and you are driven to teach and share your knowledge with the rest of the team. You have experience working with ISO 13485, ISO 14971, and MDR/IVDR-related issues. You are proficient in Swedish and English, both spoken and written.

Apply now! All you need to do is send an application via the form on our website, and we will get back to you as soon as we can. During the summer, responses may be delayed between weeks 28-32.