Informacje o stanowisku

Becoming a part of our team in the pharmaceutical and biotech industry offers a remarkable chance to profoundly affect patient health. Whether you choose to work in research and development, scientific marketing, production, or quality management, your contributions will be integral to advancing patient care and transforming the lives of people around the world.

Quality Management System Specialist

Mid/Senior

Full Time

Location: Gdynia

Biovico Sp. z o.o is a company with a strong market position, specializing in the field of medical biotechnology. Our activities are based on implementing our own innovative products, providing comprehensive solutions tailored to the needs of patients worldwide.

Position Title: Quality Management System Specialist

Responsibilities:

1. Development, verification, and updating of system documentation in accordance with ISO 13485 standard and current legal regulations;
2. Execution of tasks within the Quality Management Department;
3. Support for individual company departments in creating and updating system documentation applicable to a given organizational unit;
4. Support in quality matters during the implementation of new projects/products;
5. Initiating process and system improvements, participation in solving systemic problems;
6. Support in preparing the company for audits and certification - in accordance with implemented standards;
7. Participation in internal and external inspections and audits;
8. Working with documentation in Polish and English;
9. Evaluation of the effectiveness of implemented corrective actions;
10. Continuous improvement of processes related to the quality system;

Qualifications:

1. Experience in the field of quality management;
2. Experience in creating system documentation;
3. Quality orientation;
4. Highly developed analytical and communication skills;
5. Proficiency in English facilitating fluent communication;
6. Familiarity with the requirements of ISO 13485 standard;
7. Experience in the medical industry;
8. Specialized education related to quality management.

We offer:

• Stable and secure employment conditions based on an employment contract;
• Work tools adequate to the position held;
• Professional development through training;
• Openness to submitting own ideas.

In the CV, please include the following clause: I consent to the processing of personal data contained in this document for the purpose of the recruitment process in accordance with the Act of May 10, 2018, on the protection of personal data (Journal of Laws of 2018, item 1000) and in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (GDPR).

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I consent to the processing of my personal data contained in this document for the purposes of the recruitment process pursuant to the Personal Data Protection Act of 10 May 2018, which incorporates the provisions of the European Unions General Data Protection Regulation (GDPR) (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and repealing Directive 95/46/EC (General Data Protection Regulation).

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