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Director Quality Operations
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 Basel-Stadt Switzerland.
My client is a Class II medical devices company
You will be responsible for the Quality department which includes Quality Assurance, Regulatory Affairs and Quality Control. In this leadership role, you will manage all Quality activities to ensure that quality systems and products are effective and in compliance with regulatory expectations and quality standards. This position is a highly visible role and involves contact with multidisciplinary teams within our international company.
We are looking for a true leader who combines strategic view with operational hands on mentality and can make our quality management processes more lean and pragmatic. You will be reporting to the General Management. This position requires both National and International travelling across Europe (20%-25%).
What they are looking for a someone who has bio-technical knowledge, is a great leader, has project management skills and feels comfortable within an International growing organisation.
- Ensure compliance to regulatory requirements including QMS standards
- Lead and develop staff within the area to a high level of competency
- Further develop and implement the QMS culture within the company
- Prepare the sites for, and host, external audits (customer/regulatory) ensuring CAPA are put in place to address non-conformances
- Ensure the quality and regulatory compliance of the facility is maintained through an effective monitoring program
- Integration QMS of subsidiaries into corporate QMS
- Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process
- Ensure that validation system is in compliance with relevant external (regulatory) requirements including ISO 9001 and GMP
- A Masters degree in (Biomedical) Engineering or Biotech. Post graduate or Masters in Quality Management is a plus
- At least 5 years of management experience in Quality Assurance and Regulatory Affairs in the the medical devices, aerospace or automotive sector.
- Demonstrated experience with Class II Medical Devices (IVD, Diagnostics or alike)
- Demonstrated experience in interacting with regulatory bodies such as EMA, US FDA and the like - for registration of products as well as manufacturing compliance
- Broad experience with regulatory requirements, including ISO-13485, GMP en GDP
- The position requires a hard-working, ambitious and creative individual, with strong analytical and leadership skills
- Excellent communication skills (verbal and written) in English and German; knowledge of other languages is a plus.
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.