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Quality Systems & Regulatory Specialist
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Bern Switzerland.
My client is a small Medical Device company with aproximately 75 employees. It produces and provides medical technologies, Class I. The company is located in the vicinity of Bern, Switzerland.
This role is a very independent role. No one will be reporting to you, but you will report directly to the CEO. The major part of this role will be based at the companies production site close to Bern.
Your general responsibilities will be to ensure all service processes are customer centric and simplified to accelerate efficiency. Besides that, you will ensure all operations are ISO certified to applicable revisions of 13485 & 9001 and other standards as required by the company.
- You are the first point of contact for product compliance and regulatory matters for the company
- Coordinate maintenance of the Quality Management System (QMS) certification at global level and continuously simplify/ improve QMS processes to optimize productivity while focusing on what the customer needs
- You are the regional first point of contact for preparation and presentation to the management team of all required documentation for the legal registration, commercial release and end of life of products
- Register products for whole European market
- Audit and monitor product launch processes and compliance
- Coordinate/ participate in Quality System, Regulatory and Process audits
- Lead regional Sales and Service Quality System Management reviews of quality performance
- Facilitate identification of high priority issues relating safety, complaints and systematic customer satisfaction
- Enables rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence
- Maintain awareness of local emerging codes, standards and regulatory requirements
- Disseminate current and emerging requirements
- Provide quality and regulatory training throughout the region to ensure awareness and compliance
- Actively manage vigilance reporting and recall notification
- Actively manage the translation and publication of Quality Management System procedures, work instructions and forms within the region.
- Can handle continuous changing environment.
- Very good communicator
- International mindset
- Engineer degree or equivalent preferred
- Certified quality manager or equivalent preferred
- Knowledge of Continuous Improvement and problem-solving techniques preferred
- Verbal and written fluency in English required. Fluency in additional European languages preferred.
- ISO 9001 and 13485 Quality Management Systems standards knowledge.
- Knowledge directive 93/42 EEC for Medical devices
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.