Join us at position
QA Senior Specialist for in vitro Diagnostics
We are strengthening our Quality Assurance team and are looking for a QA senior specialist.
What will be your responsibilities?
- Work under supervision and guidance of our QA manager.
- Initiate, review and revise controlled documentation including procedures and reports to be compliant with ISO 13485:2016 and IVD Regulation (EU) 2017/746 requirements.
- Provide constructive feedback to improve QMS documentation and procedures.
- Support management and employee training.
- Lead some of the QA processes (e.g., nonconformance and CAPA identification, investigation, and resolution).
- Participate in and provide compliance guidance on product development and manufacturing procedures.
- Participate in internal and external audits, including Notified Body audits.
- Ensure that all product documents are up-to-date and in accordance with current legislation.
- Participate in discussions with developers and kit manufacturers, as well as regulatory, sales and application support teams.
Who are we looking for?
- You are a self-motivated professional with positive attitude and team spirit.
- You have finished a master’s degree or equivalent education in biochemistry, molecular biology, pharmacology, chemistry, or related fields.
- You are experienced in applying risk assessment principles according to ISO 14971 requirements.
- If you have knowledge of basic PCR methods, it is an advantage (or you have strong will to learn them).
- You have quality management system (ISO 13485:2016) experience in the medical device industry. IVD experience is highly preferred.
- If you have experience with internal/external auditing, it is a plus.
- You are proficient in both written and spoken English: QMS and technical documentation is written mostly in English.
- You have detailed experience with writing the controlled documentation in accordance with ISO 13485:2016.
- You are a highly organized person with attention to detail.
What do we offer?
- Opportunity to work on interesting and meaningful projects including novel concepts diagnostics and drug discovery in a young and dynamic biotech company with world-class research and a strong future growth.
- A professional, yet friendly and supportive work environment.
- Active sharing of know-how within the company, development of knowledge and skills.
- Possibility to gain detailed knowledge of regulation 2017/746 and ISO 13485.
- Competitive salary reflecting your seniority and the opportunity for career growth.
- Various employee benefits: 5 weeks paid vacation, meal voucher allowance, sick days, pension contribution, Multisport card, refreshments, and excellent coffee at the workplace, team buildings and many more!
- Full-time employment contract with the place of work in Zlatníky-Hodkovice near Prague.
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.
When applying, please send us 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.
