Job ID | 2024-3552 | Category | Quality |
Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
The Quality Engineer is the subject matter expert for Software as a medical device (SAMD) and/or software as an accessory/component to a medical device, and ensures the software is compliant with all regulations. This role oversees implementation of the project quality management plan(s) and product plans of the organization. He/She helps to ensure the quality, compliance, and integrity of GXP systems used in the development, manufacturing, and distribution of medical devices / In vitro devices (IVD). The role also manages projects from concept to completion; creates and manages project plan, work cross functionally to ensure completion, and ensure adequate training to impacted areas. He/She works effectively with stakeholders to ensure alignment with business objectives, correct prioritization, and successful project delivery and assists with product and process validations, including protocol and report review. If you have the required skills, don't wait, apply today!!
(This is NOT AN IT POSITION)
This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.
Quality Engineer/Medical Device/ IVD Software
Key Accountabilities:
Quality Engineer/Medical Device/ IVD Software
Minimum Knowledge & Experience required for the position:
Quality Engineer/Medical Device/ IVD Software
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com