(Senior) Quality Manager – Munich/Martinsried [QM02]
At Exosome Diagnostics GmbH in the IZB in Martinsried, we are seeking to fill a position as Sr. Quality Manager as soon as possible. Exosome Diagnostics is a developer of liquid biopsy in-vitro diagnostic devices and certified to ISO 13485. In addition, the facility in Martinsried operates a clinical laboratory accredited to ISO 15189, which performs clinical testing using in-house developed assays of patient samples submitted by doctors. We are looking for someone to be the local representative of all-things-quality. You will be working in close collaboration with our US organization, with headquarters in Boston, MA and have a reporting line to the US Head of RA/QA. As we are a small company you are expected to fill a lot of different roles and have a varied work day and a lot of responsibilities.
Key responsibilities include:
- Local head of Quality at the company’s German facility.
- Maintaining ISO 15189 accreditation, including oversight of routine patient sample testing.
- Maintaining ISO 13485 certification, including oversight of development projects under design control.
- Maintaining the electronic Quality Management System.
- Representing QA function as an independent reviewer with report to corporate QA function in US.
- Developing, writing, updating and implementing SOPs and performing employee training and internal audits.
- Responsible for compliance with appropriate quality standards and requirements (GLP, ISO 15189, ISO 13485).
- Representing QA as a team member for projects under design control
We expect that you:
- Have a relevant education in natural sciences as Technical Assistant, B.Sc. or Dipl.-Ing. or M.Sc.
- Have experience from one or more of the following: (i) an ISO 13485 QMS environment in a Quality role for IVD development with focus on product development/design control; (ii) an accredited testing laboratory (ISO 17025 or ISO 15189) in a Quality role
- Have previous working experience with Quality Management, IT systems and are computer savvy.
- Are self-motivated and know how to prioritize and schedule your own workday.
- Are systematic, meticulous and well organized.
- Experience participating in regulatory audits (ISO or FDA) is preferred.
- Are looking for a position with a lot of responsibility, flexibility and freedom in a “small” company.
- Are comfortable with English in both speech and writing to allow close communication with colleagues, many of whom are located at the company’s facilities in Boston, USA.
- Have high work ethics, high energy levels and a developed sense of humor.
- A unique opportunity to be a part of a growing company developing a cutting edge new technology for molecular diagnostics in personalized medicine.
- A central role in developing cutting edge liquid biopsy IVD products according to IVDR and FDA-QSR.
- A responsible position with the opportunity to have influence and freedom to organize your own work.
- A dynamic working environment with an opportunity to be a big fish in a small pond.
- An attractive location in the IZB campus in Martinsried near Munich.
At Exosome Diagnostics, we foster a dynamic, entrepreneurial approach to translating cutting edge science into real clinical products to benefit patients and doctors, utilizing our powerful new technologies for Biofluid Molecular Diagnostics. We encourage honest exchange of ideas and a culture of collaboration within the company to help the exceptional people who works here excel and to reach company goals.