Are you a life-science professional with a passion for quality management? Do you thrive in a dynamic environment where you can make a significant impact? Oticon Medical AB is seeking a dedicated and experienced Quality Assurance Manager to join our team.
At Oticon Medical, we develop and market bone-anchored hearing systems to help people with hearing impairment. Our product portfolio covers medical devices including electronics and software, implantable devices, surgical instruments, and accessories ranging from class I to class III.
As Quality Assurance Manager at Oticon Medical, you will be responsible for continuous development and improvement of our Quality Management System ensuring the highest standards of quality and compliance across all facets of our operations.
This position is based in our office in Gothenburg, Sweden.
Your Role
As Quality Assurance Manager, your main tasks will be to:
- Authority to take decisions regarding operational and tactical topics within the scope of our QMS
- Participate and contribute to plans and decisions on a strategic level related to our QMS
- Identify, define and implement improvement opportunities related to our QMS
- Hosting external audits
- Enforcing compliance with all Oticon Medical AB QMS procedures
- Releasing QMS procedures as the process owner
- Mandate to release products to stock and for sales
- Reviewing and approving all quality procedures according to applicable regulatory requirements, including but not limited to ISO, MDSAP, and MDR 2017/745
- Reviewing, approving, and closing CAPAs (Corrective and Preventive Actions)
- Approving Change Requests (CR) concerning QA
- Signing Change Order checklists for QA
- Collaborating with appropriate functions to approve temporary non-conformities (TPD)
Your Profile
A higher education in science or an equivalent background is required, preferably with experience in medical devices and quality management systems.
Familiarity with regulatory frameworks and standards covering medical devices and quality management is a merit.
Furthermore, you are/have:
- structured and thorough
- agile with a practical mindset, result oriented and capable of translating regulatory requirements into practical, understandable and compliant processes.
- minimum 3 years of experience in QA/RA, preferably in medical devices.
- strong knowledge of MDR, ISO 13485, MDSAP, and QSR.
- able to communicate effortlessly in English.
- willing to travel (~10 days/year).
Why Oticon Medical?
Join a collaborative and dynamic team in a trust-based environment where innovation drives better hearing solutions. We’re a fast-growing company dedicated to making a difference in people’s lives through advanced hearing solutions.
Apply Now!
Submit your CV and application through our online system by 2025-08-15. We do not accept applications via email. Please note as well that the position might close before last application date, so don’t hesitate to apply.
For questions, contact Anders Johansson, Director QARA, [email protected].
