Job Description

We are focusing on the development and production of PCR based human molecular diagnostics. We are looking for an enthusiastic colleague for the position of Senior Quality Assurance Specialist. You will work within QA/RA department, and you will lead or contribute to system and process improvement projects to ensure regulatory compliance for our innovative products in human molecular diagnostics.

MISSION

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 and manage training programs.
Manage and/or execute CAPA, change requests and nonconformances.
Participate in internal and external audits, including Notified Body audits.
Provide compliance guidance on product development and manufacturing procedures.
Ensure that all product documents are up-to-date and in accordance with current legislation.
Participate in internal discussions with other teams.

What are the requirements?

Finished Master degree in biology, chemistry, medicine or a related field.
Ability to work independently under ISO 13485, ISO 14971 and IVDR.
Experience in writing controlled documentation in the in-vitro diagnostic or medical device field (either from a development or manufacturing company, or from a consultancy).
Proficiency in both written and spoken English.
Previous experience in quality auditing, both internal and external is highly desirable.
Knowledge of basic PCR methods or immunoassays is an advantage.
You can work independently and as part of a team and have excellent time management, organisational and communication skills.

What do we offer?

A friendly work team motivated by improving the lives of people through development of new drugs and diagnostics. You will be in contact with people across the company.
Competitive salary reflecting your seniority level and your contributions.
A stimulating and diverse job in a dynamic and unique biotech company with global ambitions.
Active sharing of know-how within the company, development of knowledge and skills.
Various employee benefits: 5 weeks paid vacation, meal voucher allowance, sick days, pension contribution, Multisport card, refreshments and excellent coffee at the workplace, and more!
Full-time employment contract with place of work in Vestec near Prague, parking on site.