We are strengthening our Quality Assurance team and are looking for a QA senior specialist.
What will be your responsibilities?
- You will work under supervision and guidance of our QA manager.
- You will initiate, revise, and review controlled documentation including procedures and reports to be compliant with ISO 13485:2016 and IVD Regulation (EU) 2017/746 requirements.
- You will provide constructive feedback to improve QMS documentation and procedures.
- You will support management and employee training.
- You will lead some of the QA processes (e.g., nonconformance and CAPA identification, investigation, and resolution).
- You will participate in and provide compliance guidance for product development and manufacturing procedures.
- You will participate in internal and external audits, including audits of Notified body.
- You will ensure that all product documents are up to date and in accordance with current legislation.
- You will be involved in discussions with the developers and manufacturers of kits likewise with the regulatory and sales and application support teams.
Who are we looking for?
- Self-motivated professional with positive attitude and team spirit.
- Finished master’s degree or equivalent education in biochemistry, molecular biology, pharmacology, chemistry or related fields.
- Experience applying risk assessment principles according to ISO 14971 requirements.
- Knowledge of basic of PCR methods is a plus or strong will to learn it.
- Quality management system (ISO 13485:2016) experience in the medical device industry. IVD experience is highly preferred.
- Experience with internal/external auditing is a plus.
- Proficient in both written and spoken English: QMS and technical documentation is written mostly in English.
- Detailed experience with writing the controlled documentation in accordance with ISO 13485:2016.
- You should work in highly organized matter and with attention to details.
What do we offer?
- Friendly and supportive environment
- Diverse work in a dynamic and unique biotech company
- Perspective of a long-term contract in a successful company
- Participation in the production of unique diagnostic products
- Possibility to gain detailed knowledge of regulation 2017/746 and ISO 13485
- Opportunity to join the company at an early stage enabling your career development
- Support of further education, courses, trainings, thorough onboarding process
- Competitive salary and possibility of personal growth
- Various benefits, including five weeks paid vacation, sick days, MultiSport, pension contribution and regular company events
- Full time employment contract
About DIANA Biotechnologies
We are the most successful Czech biotechnology startup and we are just going global. We started in 2018 and since then we have built successful R&D and commercial activities in three main segments: human molecular diagnostics, small molecule drug discovery and monoclonal antibody development. We already have our products on the molecular diagnostic market and we have become the largest manufacturer of PCR tests for COVID-19 in the Czech Republic – we have brought sensitive and the most patient-friendly PCR tests from saliva to the market, multiplied the Czech testing capacity and at the same time reduced the price of the tests. We continue our mission to provide own products in diverse biotech areas as well as developing our own original medical drugs.
Although we are a young and flexible company, we have already grown to more than 100 employees. For 2021, we have become the fastest growing company in Central and Eastern Europe in the Deloitte Fast 50 Companies to watch. Our courage and healthy financial background give us the opportunity to pursue long-term and ambitious development projects with global impact. If you join us, you will be part of the creation of a unique biotechnology company that is the first of its kind in Central Europe.
If you are interested, we look forward to receiving your cover letter (describe your experience, ambitions and skills you can contribute, and explain why you want to work for us in this particular position) and CV.
Please submit your application via the form on our careers page.